Product code FLN
- Device name
- Monitor, Electric For Gravity Flow Infusion Systems
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.2420
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172242 | DripAssist Plus | Shift Labs, Inc. | 2018-05-25 |
| K150687 | DripAssist | Shift Labs | 2015-10-13 |
| K133870 | FLUID LEVEL MONITOR | Coleman Laboratories | 2014-04-24 |
| K080704 | LOW FLUID ALARM | Em-Tec GmbH | 2008-04-17 |
| K050783 | ISSYS DRUG FLOW MONITOR | Integrated Sensing Systems, Inc. | 2006-02-22 |
| K060123 | LEVELERT II FLUID LEVEL SENSOR | Smith & Nephew, Inc. | 2006-02-14 |
| K030136 | DRIP ALERT | Drip Alert, Inc. | 2003-04-07 |
| K022248 | STRYKER L3 HYDROLERT | Stryker Endoscopy | 2002-08-06 |
| K013121 | MT ALERT INFUSION MONITOR | Sierra Biosearch, Inc. | 2001-10-15 |
| K973025 | FLUID CENTURION (4-100-00) | Northgate Technologies, Inc. | 1997-11-20 |
| K972084 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 | Alexander Mfg. Co. | 1997-07-03 |
| K923561 | AC-901 I.V. INFUSION DROP COUNTER | Lamtic, Inc. | 1993-05-26 |
| K910323 | BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) | Uab Research Foundation | 1991-10-03 |
| K902808 | DRIPTROL | Trans-Pacific Healthcare-USA | 1990-10-01 |
| K903193 | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | Smith & Nephew Dyonics, Inc. | 1990-08-30 |
| K893693 | H.U. I.V. DROP COUNTER | Li-Lien Corp. | 1989-10-27 |
| K853843 | IV MATE | Medtech Intl., Inc. | 1986-01-09 |
| K853549 | MCGAW/DROP WATCH FLOW MONITOR | American Mcgaw | 1985-11-12 |
| K852433 | INFUSAFE 205 CATOLOG NO. 205.000 | Medix Medical Electronics (U.S.A.), Inc. | 1985-06-27 |
| K850710 | TRAVENOL FLO-GARD 500 IV MONITOR | Travenol Laboratories, S.A. | 1985-04-04 |
| K844227 | INFUSART | Sartorius, Inc. | 1985-01-22 |
| K844309 | IV RATEMETER | Aci Medical, Inc. | 1985-01-22 |
| K844556 | KHM 2000 DRIP WATCHER | The Timeter Group | 1985-01-14 |
| K831596 | DROP RATE COUNTER #340 | Imed Corp. | 1983-07-12 |
| K823018 | MODEL 460 INTERMITTENT MEDICATION DELIV | Y | 1983-01-26 |
| K821823 | I.V. SENTINEL | The John Bunn Co. | 1982-08-16 |
| K802166 | MODEL AS* 7B AUTOSYRINGE INFUSION PUMP | Baxter Healthcare Corp | 1980-11-12 |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | Pollak (Intl.), Ltd. | 1980-10-31 |
| K801734 | IMED DROP RATE CALCULATOR #340 | Imed Corp. | 1980-10-23 |
| K802101 | I.V. SENTRY ALARM DEVICE | Pike Medical Co. | 1980-09-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00845699046447 | Agiliti - Essentia | SIZEWISE RENTALS, L.L.C. | 2026-05-08 |
| 00884838093188 | Avalon Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00850024592070 | Hometa | Hometa, Inc. | 2020-11-05 |
| 00885556704127 | NA | Smith & Nephew, Inc. | 2017-10-26 |
| 03596010121233 | NA | Smith & Nephew, Inc. | 2017-08-15 |
| 00885556561423 | NA | Smith & Nephew, Inc. | 2017-08-15 |
| 00885556632598 | NA | Smith & Nephew, Inc. | 2017-08-15 |
| 00885556571071 | NA | Smith & Nephew, Inc. | 2017-06-15 |
| 00856220006007 | DripAssist | SHIFT LABS, INC. | 2016-04-01 |
| 03596010121196 | NA | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010121202 | NA | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010556011 | LEVELERT | Smith & Nephew, Inc. | 2015-08-30 |