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

Ipax, Inc. — Predicate Candidate Screening

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

65 daysmedian FDA review time

259 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K200893	ProntoPump Sterile Tube Set	Ipax, Inc.	2021-05-04	396
K971242	BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)	Ipax, Inc.	1997-12-17	259
K971245	BLINK EXTERNAL EYELID WEIGHT	Ipax, Inc.	1997-06-20	78
K915158	SUREBREATH DOME, E-Z BREATHER	Ipax, Inc.	1992-02-12	90
K915118	PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE	Ipax, Inc.	1991-12-27	44
K914172	KPE 230 AM	Ipax, Inc.	1991-10-25	60
K914221	KPE 220 TS, NONSTERILE	Ipax, Inc.	1991-10-25	63
K884076	SUREBREATH DOME	Ipax, Inc.	1988-10-07	10
K873097	PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS	Ipax, Inc.	1987-09-04	39
K870770	TIMLEINE(TM) VENIPUNCTURE SYSTEM	Ipax, Inc.	1987-04-23	56
K864726	I/A/KPE TIP	Ipax, Inc.	1987-01-20	85
K863729	OPHTHALMIC FITLER MICRO CAPSULE	Ipax, Inc.	1986-10-10	17
K863209	US PLUS-PAK(R) SURGICAL SYSTEM	Ipax, Inc.	1986-09-08	19
K862334	CATALOG NO. I/A 100 AND KPE 200	Ipax, Inc.	1986-07-08	28
K860609	TIMELINE VENIPUNCTURE SYSTEM	Ipax, Inc.	1986-06-04	105
K861182	TIMELINE VENIPUNCTURE SYSTEM	Ipax, Inc.	1986-06-04	65
K833961	I/A PLUS PAK SURGICAL SYSTEM	Ipax, Inc.	1984-03-12	117
K833962	KPE PLUS-PAK SURGICAL SYSTEM	Ipax, Inc.	1984-03-12	117

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