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

Porex Medical · Predicate Candidate Screening

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

39 daysmedian FDA review time

140 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K872791	POREX NERVE LOCATOR	Porex Medical	1987-10-20	98	0
K873044	POREX OTOLOGY INSTRUMENTS	Porex Medical	1987-09-04	31	0
K872947	POREX QUALITY PLASTIC SURGERY INSTRUMENTS	Porex Medical	1987-08-21	24	0
K863943	POREX(TM) EYE SPHERE IMPLANT	Porex Medical	1987-02-27	140	1
K863946	POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT	Porex Medical	1987-02-27	140	0
K870182	POREX(TM) MALAR IMPLANT	Porex Medical	1987-02-24	39	0
K870257	POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.	Porex Medical	1987-02-24	32	0
K870154	POREX(TM) TISSUE EXPANDER	Porex Medical	1987-02-24	42	0
K863939	POREX(TM) EAR PROSTHESIS	Porex Medical	1986-10-24	14	0
K863941	POREX(TM) PROSTHESIS, CHIN, INTERNAL	Porex Medical	1986-10-24	14	0
K863942	POREX(TM) NOSE PROSTHESIS	Porex Medical	1986-10-24	14	0
K860503	THE POREX RETRACTOR TABLE	Porex Medical	1986-03-13	30	0
K832283	MEDPAR SURGICAL IMPLANTS	Porex Medical	1984-05-10	303	0
K833586	TLS BULB DRAINAGE SYSTEM	Porex Medical	1984-01-30	110	2
K831372	TLS SURGICAL MARKER	Porex Medical	1983-06-24	58	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