Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

FLN — Predicate Candidate Screening

39 FDA 510(k) clearances under this product code; the 50 most recent screened below.

72 daysmedian FDA review time

252 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K172242	DripAssist Plus	Shift Labs, Inc.	2018-05-25	303
K150687	DripAssist	Shift Labs	2015-10-13	210
K133870	FLUID LEVEL MONITOR	Coleman Laboratories	2014-04-24	125
K080704	LOW FLUID ALARM	Em-Tec GmbH	2008-04-17	36
K050783	ISSYS DRUG FLOW MONITOR	Integrated Sensing Systems, Inc.	2006-02-22	331
K060123	LEVELERT II FLUID LEVEL SENSOR	Smith & Nephew, Inc.	2006-02-14	27
K030136	DRIP ALERT	Drip Alert, Inc.	2003-04-07	83
K022248	STRYKER L3 HYDROLERT	Stryker Endoscopy	2002-08-06	25
K013121	MT ALERT INFUSION MONITOR	Sierra Biosearch, Inc.	2001-10-15	27
K973025	FLUID CENTURION (4-100-00)	Northgate Technologies, Inc.	1997-11-20	98
K972084	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER	Alexander Mfg. Co.	1997-07-03	29
K923561	AC-901 I.V. INFUSION DROP COUNTER	Lamtic, Inc.	1993-05-26	313
K910323	BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)	Uab Research Foundation	1991-10-03	252
K902808	DRIPTROL	Trans-Pacific Healthcare-USA	1990-10-01	96
K903193	SMITH & NEPHEW DYONICS LEVELERT SYSTEM	Smith & Nephew Dyonics, Inc.	1990-08-30	42
K893693	H.U. I.V. DROP COUNTER	Li-Lien Corp.	1989-10-27	164
K853843	IV MATE	Medtech Intl., Inc.	1986-01-09	115
K853549	MCGAW/DROP WATCH FLOW MONITOR	American Mcgaw	1985-11-12	78
K852433	INFUSAFE 205 CATOLOG NO. 205.000	Medix Medical Electronics (U.S.A.), Inc.	1985-06-27	17
K850710	TRAVENOL FLO-GARD 500 IV MONITOR	Travenol Laboratories, S.A.	1985-04-04	41
K844227	INFUSART	Sartorius, Inc.	1985-01-22	82
K844309	IV RATEMETER	Aci Medical, Inc.	1985-01-22	77
K844556	KHM 2000 DRIP WATCHER	The Timeter Group	1985-01-14	54
K831596	DROP RATE COUNTER #340	Imed Corp.	1983-07-12	56
K823018	MODEL 460 INTERMITTENT MEDICATION DELIV	Y	1983-01-26	105
K821823	I.V. SENTINEL	The John Bunn Co.	1982-08-16	55
K802166	MODEL AS* 7B AUTOSYRINGE INFUSION PUMP	Baxter Healthcare Corp	1980-11-12	65
K802011	INFUSSION ALARM SYSTEM I.A.S. CAT.#1118	Pollak (Intl.), Ltd.	1980-10-31	72
K801734	IMED DROP RATE CALCULATOR #340	Imed Corp.	1980-10-23	90
K802101	I.V. SENTRY ALARM DEVICE	Pike Medical Co.	1980-09-16	13
K790836	GUARDIAN II I.V. CONTROLLER	Centaur Sciences, Inc.	1979-07-30	91
K790669	DROP CONTROLLER	Imed Corp.	1979-05-14	38
K781589	VOLUMETRIC CONTROLLER MODEL 310	Imed Corp.	1978-11-22	65
K781717	MONITOR, GRAVITY IRRIGATION DRIP	Syntel, Inc.	1978-10-27	16
K781297	INTRA-ALERT	Pan-Tech Research, Inc.	1978-10-25	90
K780223	PARENTERAL INFUSION CONTROLLER	Travenol Laboratories, S.A.	1978-04-10	60
K780106	PARENTERAL INFUSION CONTROLLER, ELEC.	National Patent Development Corp.	1978-02-21	32
K760931	I.V. DRIP MONITOR ALARM DEVICE, MONIFLO	Diemolding Corp.	1977-01-05	68
K760694	ARNCO I.V. MONITOR	A.R. Nelson Co., Inc.	1976-12-23	92

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda