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

Sims Portex, Inc. — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time

200 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K011925	HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE;	Sims Portex, Inc.	2001-07-12	22	1
K002201	ELECTROSTATIC HYDROPHOBIC BREATHING FILTER	Sims Portex, Inc.	2001-02-05	200	0
K002506	BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT	Sims Portex, Inc.	2000-12-14	121	0
K001318	CPAP SYSTEM, MODEL 102001	Sims Portex, Inc.	2000-07-20	85	0
K993619	CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK	Sims Portex, Inc.	2000-04-28	185	0
K994275	SIMS PORTEX ANESTHESIA CATHETER	Sims Portex, Inc.	2000-02-22	64	0
K991861	1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST R	Sims Portex, Inc.	2000-01-18	231	0
K992471	SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MO	Sims Portex, Inc.	1999-10-22	88	0
K992057	IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008	Sims Portex, Inc.	1999-09-13	87	0
K983858	SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES	Sims Portex, Inc.	1999-01-29	88	0
K981035	PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES	Sims Portex, Inc.	1998-04-21	33	0
K980466	PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIA	Sims Portex, Inc.	1998-02-24	18	1

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