FDA Product Code
FDA Product Code KME — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6060
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K042145 | READY-HEAT BLANKET | Techtrade, LLC | 2004-09-17 | Traditional | PDF ↗ |
| K944953 | OREX MEDICAL BEDDING | Thantex Specialties, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K933636 | DISPOSE-A-SHEET | Belmac Healthcare Corp. | 1994-01-26 | Traditional | PDF ↗ |
| K932539 | DOCTOR DOWN --RESCUE WRAP | Three Dog Down | 1993-11-02 | Traditional | PDF ↗ |
| K922143 | AMERICAN BURN SHEET | American Silk Sutures, Inc. | 1992-08-10 | Traditional | PDF ↗ |
| K915303 | FOIL BABY BUNTING | Gam Industries, Inc. | 1992-02-20 | Traditional | PDF ↗ |
| K912257 | CHEM-SLEEVE B | Haz-Med, Inc. | 1991-12-31 | Traditional | PDF ↗ |
| K911952 | MEDI GUARD UNDERPAD | Sancella, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K911948 | MEDI GUARD PILLOWCASE | Sancella, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K911953 | MEDI GUARD SHEETS/UNDERLAYS | Sancella, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K911950 | MEDI GUARD DRAPES | Sancella, Inc. | 1991-05-21 | Traditional | PDF ↗ |
| K905003 | BIO-GUARD SHAVE PREP TRAY | Network Medical Systems, Inc. | 1990-12-28 | Traditional | PDF ↗ |
| K904274 | RECEIVING BLANKET | Anago, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K901509 | TRAUMA SLEEVE | Haz-Med, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K901629 | CHEM-SLEEVE | Haz-Med, Inc. | 1990-04-27 | Traditional | PDF ↗ |
| K900643 | FLUID SOAKERSHIELD | Infection Control Products, Inc. | 1990-04-25 | Traditional | PDF ↗ |
| K896043 | MATTRESS COVER FOR MEDICAL PURPOSES | Keystone Veterinary Supplies, Inc. | 1990-01-10 | Traditional | PDF ↗ |
| K891986 | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE | Mark One Healthcare Products | 1989-12-29 | Traditional | PDF ↗ |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Devon Industries, Inc. | 1989-09-07 | Traditional | PDF ↗ |
| K884380 | BED SHEET, PILLOW CASE | Saybrex Intl., Inc. | 1988-11-08 | Traditional | PDF ↗ |
| K882332 | HEADREST, PATIENT COMFORT | Surgic Aid, Inc. | 1988-07-19 | Traditional | PDF ↗ |
| K881969 | DRY COMFORT DISPOSABLE UNDERPAD | Health Tec, Inc. | 1988-06-07 | Traditional | PDF ↗ |
| K881859 | DRIPRIDE DISPOSABLE UNDERPAD | Weyerhaeuser Co. | 1988-06-03 | Traditional | PDF ↗ |
| K871725 | DRIPRIDE DISPOSABLE UNDERPADS | Weyerhaeuser Co. | 1987-05-15 | Traditional | PDF ↗ |
| K870925 | PAD, BED LINEN PROTECTIVE | Quality Disposables, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K870522 | DEPEND UNDERPAD | Kimberly-Clark Corp. | 1987-03-13 | Traditional | PDF ↗ |
| K864158 | THERMAPAD | Avail-Southwest Division | 1987-03-02 | Traditional | PDF ↗ |
| K863179 | KIMLON DISPOSABLE BLANKET | Kimberly-Clark Corp. | 1986-08-27 | Traditional | PDF ↗ |
| K862348 | SINGLE-USE PATIENT UNDERPAD | Procter & Gamble Mfg. Co. | 1986-07-02 | Traditional | PDF ↗ |
| K860066 | REFLECTIVE BLANKET | O.R. Concepts, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K853970 | ALPHA CHUCK | Rocky Mountain Medical Corp. | 1985-11-08 | Traditional | PDF ↗ |
| K853880 | ATTENDS DISPOS. UNDERPAD | Procter & Gamble Mfg. Co. | 1985-10-16 | Traditional | PDF ↗ |
| K850067 | MEDICAL, DISPOSABLE BEDDING | East Texas Lighthouse For the Blind | 1985-04-19 | Traditional | PDF ↗ |
| K850811 | PAD, PRE-OPERATIVE PREPARATION | East Texas Lighthouse For the Blind | 1985-03-21 | Traditional | PDF ↗ |
| K850544 | SHAVE PREP TRAY | Packaging Technologies, Inc. | 1985-03-12 | Traditional | PDF ↗ |
| K842989 | SHAVE PREP KITS | Biological & Environmental Control Laboratories | 1984-12-04 | Traditional | PDF ↗ |
| K844196 | WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT | Biological & Environmental Control Laboratories | 1984-12-04 | Traditional | PDF ↗ |
| K843038 | DISPOSABLE PATIENT BLANKET | Anago, Inc. | 1984-10-24 | Traditional | PDF ↗ |
| K843402 | MOLINEA UNDERPADS | Paul Hartmann Corp. | 1984-09-07 | Traditional | PDF ↗ |
| K842335 | PILLOW W/STAPHCHEK TICKING | Monterey Mills, Inc. | 1984-08-01 | Traditional | PDF ↗ |
| K842336 | DISPOSABLE PILLOW | Monterey Mills, Inc. | 1984-07-13 | Traditional | PDF ↗ |
| K832487 | DRAW SHEET, ANTI-MICROBIAL | American Threshold Industries, Inc. | 1984-02-13 | Traditional | PDF ↗ |
| K832486 | PILLOW COVER, ANTI-MICROBIAL | American Threshold Industries, Inc. | 1984-02-13 | Traditional | PDF ↗ |
| K822650 | SUPER DONUT | Alimed, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K821835 | BARRIER BURN SHEET | Uhi Corp. | 1982-07-02 | Traditional | PDF ↗ |
| K820582 | 3M THINSULATE DISPOSABLE HOSPITAL BED | 3M Company | 1982-03-18 | Traditional | PDF ↗ |
| K813519 | NON-ABSORBENT TOWELS | Cunningham Woodland, Inc. | 1982-01-05 | Traditional | PDF ↗ |
| K813263 | PATIENT UNDERPAD | The Buckeye Cellulose Corp. | 1981-11-27 | Traditional | PDF ↗ |
| K812079 | DISPOSABLE PILLOW | Carpenter Co. | 1981-08-04 | Traditional | PDF ↗ |
| K811232 | DISPOSABLE UNDERPADS | Burina | 1981-05-21 | Traditional | PDF ↗ |
| K810264 | DISPOSABLE PILLOW | Anago, Inc. | 1981-02-09 | Traditional | PDF ↗ |
| K802998 | PATIENT CARE DISPOSABLE INFANT SHIRTS | American Convertors Div., American Pharmaseal | 1980-12-22 | Traditional | PDF ↗ |
| K802730 | FLUFF UNDERPAD TYPE UP1002 | Bio D Corp. | 1980-12-10 | Traditional | PDF ↗ |
| K802740 | FLUFF UNDERPAD TYPE UP1001 | Bio D Corp. | 1980-12-10 | Traditional | PDF ↗ |
| K792626 | STERILIZATION PROCESS/BABY BLANKET | Procter & Gamble Mfg. Co. | 1980-01-16 | Traditional | PDF ↗ |
| K790411 | AUTO TRAUMA KIT | Marshall Electronics, Inc. | 1979-06-01 | Traditional | PDF ↗ |
| K790659 | INFANT SCALE DISPOSABLE LINER | Hydro-Med Products, Inc. | 1979-04-30 | Traditional | PDF ↗ |
| K790283 | PILLOW, CARTER ARM ELEVATION | Depuy, Inc. | 1979-04-06 | Traditional | PDF ↗ |
| K781796 | BEDDING, DISPOSABLE HOSPITAL | Kimberly-Clark Corp. | 1978-12-07 | Traditional | PDF ↗ |
| K782001 | ROSEALAE | Asmb | 1978-12-07 | Traditional | PDF ↗ |
| K781227 | TOWELS, SHEETS, PILLOWCASES | Abco Dealers, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K781354 | PILLOWS- SINGLE PATIENT USE | Abco Dealers, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K770486 | SHEET KIT, STRETCHER, DISPOSABLE | American Hospital Supply Corp. | 1977-04-29 | Traditional | PDF ↗ |
| K761109 | TERRYCLOTH BIBS | Fred Sammons, Inc. | 1976-12-02 | Traditional | PDF ↗ |
| K761108 | PLASTIC DISPOSABLE BIB | Fred Sammons, Inc. | 1976-12-02 | Traditional | PDF ↗ |
Product code KME · Class I · General Hospital. Data: openFDA.