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

Tri-Med, Inc. — Predicate Candidate Screening

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

45 daysmedian FDA review time

117 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days
K040112	TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE	Tri-Med, Inc.	2004-03-12	52
K030877	TRIMED RADIAL BULLET	Tri-Med, Inc.	2004-02-05	322
K010545	TBW	Tri-Med, Inc.	2001-06-06	103
K961863	PARACENTESIS TRAYS	Tri-Med, Inc.	1996-05-28	14
K875224	HUDSON CRANINAL BURRS	Tri-Med, Inc.	1988-01-28	37
K850747	TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR	Tri-Med, Inc.	1985-04-02	36
K850745	TRI-MED MODEL 112 MOISTURE TRAP	Tri-Med, Inc.	1985-04-02	36
K850746	TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI	Tri-Med, Inc.	1985-04-02	36
K843681	RESPIRATION & HEART RATE MONITOR 530	Tri-Med, Inc.	1984-12-04	77
K843285	TRI-MED 610 CAPNOSTAT GAS ANALYZER	Tri-Med, Inc.	1984-11-13	84
K842399	48 HOUR SET CHANGES	Tri-Med, Inc.	1984-10-09	112
K840248	IV-FILTER	Tri-Med, Inc.	1984-04-20	92
K832093	FEEDING GASTROSTOMY TUBE	Tri-Med, Inc.	1984-02-04	221
K834130	INTRAVENOUS FILTER SET	Tri-Med, Inc.	1984-01-30	77
K833397	TRI-MED 511 INFANT RESPIRATION MONITOR	Tri-Med, Inc.	1983-11-28	59
K831315	TRILEX	Tri-Med, Inc.	1983-08-12	112
K831350	IVFLO-HP & IVFIL-HP FILTER	Tri-Med, Inc.	1983-08-12	109
K823690	IVFLO-HP & IVFIL-HP	Tri-Med, Inc.	1982-12-28	20
K822819	TRIMED 510 APNEA MONITOR	Tri-Med, Inc.	1982-11-04	45
K820459	VIRAGARD/VIRASHIELD	Tri-Med, Inc.	1982-06-16	117
K812615	TM-CAPD	Tri-Med, Inc.	1982-01-05	112
K813014	PROTECT-O-SEAL	Tri-Med, Inc.	1981-11-10	14
K813001	FIBRI-FILTER 20	Tri-Med, Inc.	1981-11-06	11
K812457	HIFLO-HP	Tri-Med, Inc.	1981-09-21	21
K811859	BACTASHIELD	Tri-Med, Inc.	1981-08-07	37
K811981	ISOLATER THP	Tri-Med, Inc.	1981-08-04	22
K811773	BACTAGARD	Tri-Med, Inc.	1981-07-13	21
K790346	ACTIVATOR	Tri-Med, Inc.	1979-03-21	28
K770213	BARIOR	Tri-Med, Inc.	1977-02-07	5

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