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

Byron Medical · Predicate Candidate Screening

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

47 daysmedian FDA review time

163 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K040149	PSI-TEC PERISTALTIC INFILTRATION PUMP	Byron Medical	2004-06-03	132
K001803	ACCELERATOR RECIPROCATING CANNULA	Byron Medical	2000-08-04	51
K981215	PSI-TEC LIPOSUCTION ASPIRATOR	Byron Medical	1998-07-01	90
K981172	LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CA	Byron Medical	1998-06-30	90
K980738	PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FL	Byron Medical	1998-06-16	111
K980392	PSI-TEC ASPIRATOR	Byron Medical	1998-03-05	31
K974295	BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING	Byron Medical	1998-02-10	88
K973133	BIG BAG 3000 PRESSURE INFUSOR	Byron Medical	1997-09-12	22
K934179	DISPOSABLE BAG DECANTER	Byron Medical	1994-05-23	270
K934233	ZARA ZONE IV MALAR IMPLANT MODIFICATION	Byron Medical	1994-02-03	157
K933670	BIOPSY PUNCH, SURGICAL	Byron Medical	1994-01-07	163
K913882	ZARA SILICONE BLOCK	Byron Medical	1992-04-21	236
K914016	ZARA ZONE IV MALAR IMPLANT	Byron Medical	1991-12-05	87
K910436	ELASTIC ADHESIVE BANDAGE	Byron Medical	1991-03-19	47
K910458	ZARA SOFT TIP CHIN IMPLANT	Byron Medical	1991-02-19	15
K910456	ZARA CHIN IMPLANT	Byron Medical	1991-02-19	15
K910457	ZARA EXTENDED CHIN IMPLANT	Byron Medical	1991-02-19	15
K895865	SERENE WRAP	Byron Medical	1989-12-27	86
K881460	SMOKEVAC ELECTORSURGICAL PENCIL	Byron Medical	1988-05-04	27
K863397	BYRON SILICONE CHIN IMPLANTS	Byron Medical	1986-09-18	15
K863430	BYRON BIVALVE NASAL SPLINTS	Byron Medical	1986-09-17	13
K863399	BYRON DORSAL COLUMELLA IMPLANT	Byron Medical	1986-09-17	14
K863398	BYRON NASAL SEPTAL BUTTON	Byron Medical	1986-09-17	14
K863400	BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR	Byron Medical	1986-09-17	14
K862936	NEWMAN CANNULAE SYSTEM (NCS)	Byron Medical	1986-08-14	10
K861878	BYRON SUCTION TIPS	Byron Medical	1986-07-01	47
K861877	BYRON WORD BARTHOLIAN GLAND CATHETER	Byron Medical	1986-05-30	15

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