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

Treace Medical, Inc. — Predicate Candidate Screening

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

31 daysmedian FDA review time

144 days90th percentile

80clearances measured

K-number	Device	Applicant	Decided	Review days
K883727	BUCKET PROSTHESIS PORP	Treace Medical, Inc.	1989-01-13	135
K882349	MALLET, SURGICAL	Treace Medical, Inc.	1988-06-23	16
K874779	BIPOLATOR 50	Treace Medical, Inc.	1988-01-29	71
K873154	TREACE MAGNUM OTO-TOOL SYSTEM	Treace Medical, Inc.	1987-09-04	24
K872000	EYE GARD	Treace Medical, Inc.	1987-07-21	56
K870765	CANNULATED INSTRUMENT CLEANERS	Treace Medical, Inc.	1987-05-27	90
K871706	OPTHA PREP	Treace Medical, Inc.	1987-05-18	17
K870759	CLEANING SOLUTION, CATALOG NO. 8203	Treace Medical, Inc.	1987-05-07	70
K870766	PROSTHESIS WIRE	Treace Medical, Inc.	1987-04-15	48
K870763	SUPER SCISSORS	Treace Medical, Inc.	1987-03-18	20
K870760	BUR BRUSH	Treace Medical, Inc.	1987-03-18	20
K870764	SCHUKNECHT WIRE CUTTING SCISSORS	Treace Medical, Inc.	1987-03-18	20
K870757	OTOLOGICAL METRIC SCALE/GAUGE	Treace Medical, Inc.	1987-03-06	8
K870762	EAR APPLICATOR, CATALOG NO. 2229	Treace Medical, Inc.	1987-03-06	8
K870758	SMALL MASTOID RETRACTOR	Treace Medical, Inc.	1987-03-04	6
K870761	EAR LOOP	Treace Medical, Inc.	1987-03-03	5
K870756	VEIN GRAFT EAR SCISSORS	Treace Medical, Inc.	1987-03-03	5
K863382	CANNON NASAL SPLINT	Treace Medical, Inc.	1986-10-07	34
K863412	BIPOL CABLE	Treace Medical, Inc.	1986-10-02	29
K863413	BIPOLFORCEPS	Treace Medical, Inc.	1986-10-02	29
K863414	MICROBIPOLATOR	Treace Medical, Inc.	1986-09-17	14
K862807	TREACE DRILL SYSTEM	Treace Medical, Inc.	1986-08-15	23
K862584	OSTEOTOMY DRAINAGE TUBE	Treace Medical, Inc.	1986-08-12	36
K862582	TREACE MEDICAL MICRO INSTRUMENT WIPE	Treace Medical, Inc.	1986-07-30	23
K862583	LITE TOUCH GELFOAM INSERT	Treace Medical, Inc.	1986-07-21	14
K861914	TREACE MEDICAL FOAM INSTRUMENT PAD	Treace Medical, Inc.	1986-06-06	18
K861915	SURGICAL HEAD SUPPORT	Treace Medical, Inc.	1986-05-30	11
K844378	OIL, MINERAL	Treace Medical, Inc.	1985-03-18	125
K844377	SILICONE	Treace Medical, Inc.	1985-03-18	125
K844379	STONE, INSTRUMENT HONING	Treace Medical, Inc.	1984-11-29	16
K834094	AUSTIN ENDOLYMPH DISPERSMENT SHUNT	Treace Medical, Inc.	1984-09-20	297
K841357	MICRO FLUID APPLICATOR	Treace Medical, Inc.	1984-08-24	144
K841356	ELEVATOR	Treace Medical, Inc.	1984-07-18	107
K841359	FENESTRA HOOK	Treace Medical, Inc.	1984-07-18	107
K841353	CAUSSE SPONGE BOAT	Treace Medical, Inc.	1984-07-06	95
K841354	CURETTE	Treace Medical, Inc.	1984-07-06	95
K841355	RIGHT ANGLED PICK	Treace Medical, Inc.	1984-07-03	92
K834093	PERFORATOR BUR	Treace Medical, Inc.	1984-05-02	156
K823910	DONALDSON VENT TUBE	Treace Medical, Inc.	1983-11-22	329
K823918	AUSTIN MODIFIED PARTIAL OSSICULAR RE-	Treace Medical, Inc.	1983-06-24	178
K823912	AUSTIN MODIFIED TOTAL OSSICULAR REPLACE	Treace Medical, Inc.	1983-06-24	178
K823917	PARTIAL OSSICULAR REPLACEMENT	Treace Medical, Inc.	1983-06-24	178
K823919	TOTAL OSSICULAR REPLACEMENT	Treace Medical, Inc.	1983-06-24	178
K831589	VENT TUBE FORCEPS	Treace Medical, Inc.	1983-06-16	30
K831588	INSTRUMENT GUARD CAPSULE	Treace Medical, Inc.	1983-06-15	29
K831590	T-TUBE INSERTER	Treace Medical, Inc.	1983-06-15	29
K830584	SOILEAU TYTAN BOBBIN VENT TUBE	Treace Medical, Inc.	1983-06-02	99
K823909	T-TUBE VENT TUBE	Treace Medical, Inc.	1983-03-17	79
K823907	COLLAR BUTTON VENT TUBE	Treace Medical, Inc.	1983-01-28	31
K823908	GROMMET VENT TUBE	Treace Medical, Inc.	1983-01-28	31

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