FDA Product Code
FDA Product Code FLN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.2420
510(k) Clearances — 39 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172242 | DripAssist Plus | Shift Labs, Inc. | 2018-05-25 | Traditional | PDF ↗ |
| K150687 | DripAssist | Shift Labs | 2015-10-13 | Traditional | PDF ↗ |
| K133870 | FLUID LEVEL MONITOR | Coleman Laboratories | 2014-04-24 | Traditional | PDF ↗ |
| K080704 | LOW FLUID ALARM | Em-Tec GmbH | 2008-04-17 | Abbreviated | PDF ↗ |
| K050783 | ISSYS DRUG FLOW MONITOR | Integrated Sensing Systems, Inc. | 2006-02-22 | Traditional | PDF ↗ |
| K060123 | LEVELERT II FLUID LEVEL SENSOR | Smith & Nephew, Inc. | 2006-02-14 | Special | PDF ↗ |
| K030136 | DRIP ALERT | Drip Alert, Inc. | 2003-04-07 | Traditional | PDF ↗ |
| K022248 | STRYKER L3 HYDROLERT | Stryker Endoscopy | 2002-08-06 | Traditional | PDF ↗ |
| K013121 | MT ALERT INFUSION MONITOR | Sierra Biosearch, Inc. | 2001-10-15 | Traditional | PDF ↗ |
| K973025 | FLUID CENTURION (4-100-00) | Northgate Technologies, Inc. | 1997-11-20 | Traditional | PDF ↗ |
| K972084 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 | Alexander Mfg. Co. | 1997-07-03 | Traditional | PDF ↗ |
| K923561 | AC-901 I.V. INFUSION DROP COUNTER | Lamtic, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K910323 | BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) | Uab Research Foundation | 1991-10-03 | Traditional | PDF ↗ |
| K902808 | DRIPTROL | Trans-Pacific Healthcare-USA | 1990-10-01 | Traditional | PDF ↗ |
| K903193 | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | Smith & Nephew Dyonics, Inc. | 1990-08-30 | Traditional | PDF ↗ |
| K893693 | H.U. I.V. DROP COUNTER | Li-Lien Corp. | 1989-10-27 | Traditional | PDF ↗ |
| K853843 | IV MATE | Medtech Intl., Inc. | 1986-01-09 | Traditional | PDF ↗ |
| K853549 | MCGAW/DROP WATCH FLOW MONITOR | American Mcgaw | 1985-11-12 | Traditional | PDF ↗ |
| K852433 | INFUSAFE 205 CATOLOG NO. 205.000 | Medix Medical Electronics (U.S.A.), Inc. | 1985-06-27 | Traditional | PDF ↗ |
| K850710 | TRAVENOL FLO-GARD 500 IV MONITOR | Travenol Laboratories, S.A. | 1985-04-04 | Traditional | PDF ↗ |
| K844309 | IV RATEMETER | Aci Medical, Inc. | 1985-01-22 | Traditional | PDF ↗ |
| K844227 | INFUSART | Sartorius, Inc. | 1985-01-22 | Traditional | PDF ↗ |
| K844556 | KHM 2000 DRIP WATCHER | The Timeter Group | 1985-01-14 | Traditional | PDF ↗ |
| K831596 | DROP RATE COUNTER #340 | Imed Corp. | 1983-07-12 | Traditional | PDF ↗ |
| K823018 | MODEL 460 INTERMITTENT MEDICATION DELIV | Y | 1983-01-26 | Traditional | PDF ↗ |
| K821823 | I.V. SENTINEL | The John Bunn Co. | 1982-08-16 | Traditional | PDF ↗ |
| K802166 | MODEL AS* 7B AUTOSYRINGE INFUSION PUMP | Baxter Healthcare Corp | 1980-11-12 | Traditional | PDF ↗ |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | Pollak (Intl.), Ltd. | 1980-10-31 | Traditional | PDF ↗ |
| K801734 | IMED DROP RATE CALCULATOR #340 | Imed Corp. | 1980-10-23 | Traditional | PDF ↗ |
| K802101 | I.V. SENTRY ALARM DEVICE | Pike Medical Co. | 1980-09-16 | Traditional | PDF ↗ |
| K790836 | GUARDIAN II I.V. CONTROLLER | Centaur Sciences, Inc. | 1979-07-30 | Traditional | PDF ↗ |
| K790669 | DROP CONTROLLER | Imed Corp. | 1979-05-14 | Traditional | PDF ↗ |
| K781589 | VOLUMETRIC CONTROLLER MODEL 310 | Imed Corp. | 1978-11-22 | Traditional | PDF ↗ |
| K781717 | MONITOR, GRAVITY IRRIGATION DRIP | Syntel, Inc. | 1978-10-27 | Traditional | PDF ↗ |
| K781297 | INTRA-ALERT | Pan-Tech Research, Inc. | 1978-10-25 | Traditional | PDF ↗ |
| K780223 | PARENTERAL INFUSION CONTROLLER | Travenol Laboratories, S.A. | 1978-04-10 | Traditional | PDF ↗ |
| K780106 | PARENTERAL INFUSION CONTROLLER, ELEC. | National Patent Development Corp. | 1978-02-21 | Traditional | PDF ↗ |
| K760931 | I.V. DRIP MONITOR ALARM DEVICE, MONIFLO | Diemolding Corp. | 1977-01-05 | Traditional | PDF ↗ |
| K760694 | ARNCO I.V. MONITOR | A.R. Nelson Co., Inc. | 1976-12-23 | Traditional | PDF ↗ |
Product code FLN · Class II · General Hospital. Data: openFDA.