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

FLS — Predicate Candidate Screening

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

84 daysmedian FDA review time

287 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K011597	SMARTMONITOR 2, MODEL 4000	Respironics Georgia, Inc.	2002-01-11	232	2
K991087	HANNAH WIRELESS VITAL SIGNS MONITOR	Ilife Systems, Inc.	2000-01-12	287	0
K962865	REMBRANDT SYSTEM	Airsep Corp.	1996-10-25	94	0
K951246	PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPE	Protocol Systems, Inc.	1996-02-02	319	0
K894973	RESPITRACE PLUS	Hogan & Hartson	1989-10-30	84	0
K832999	RESPIRATION MONITOR	Litton Medical Electronics	1984-02-13	179	0
K830778	MONITORING KIT AMK-1	Alternative Design Systems, Inc.	1983-10-14	217	0
K822077	RESPIRATION MONITOR TYPE MR-10	New Dimensions IN Medicine, Inc.	1982-10-06	83	0
K821721	CLINICAL DATA APNEA DETECTOR	Clinical Data, Inc.	1982-07-13	33	0
K820943	SYSTEM I INFANT MONITORING SYS	Burr Engineering & Development Co.	1982-05-03	27	0
K810153	VENTILATORY EFFORT MONITOR	Medicon, Inc.	1981-02-09	19	0
K802710	INFANT APNEA MONITOR	Douglas Scientific Products	1980-11-12	12	0
K800164	413A NEONATAL MONITOR	Xerox Corp.	1980-04-10	76	0
K781216	INFUSION CONTROLLER, PARENTERAL	National Patent Development Corp.	1978-08-10	24	0
K760635	MEDI-DYNE APNEA MONITOR	Med Dyne Inst., Inc.	1976-09-21	8	0
K760104	RESPIRATION MONITOR	Air-Shields, Inc.	1976-09-21	90	0

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