Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HXB — Predicate Candidate Screening

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

27 daysmedian FDA review time

93 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K960539	DIAO HAND SURGERY SET	Kinetikos Medical, Inc.	1996-07-23	167
K943472	COHORT AVB RETRACTOR SYSTEM	Cohort Medical Products Group, Inc.	1994-10-20	93
K912843	FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE	Flexmedics	1991-09-24	90
K890227	SURGICAL PROBE	Kinetic Medical Products	1989-01-27	9
K873652	HOOK PROBE #TM-1376	Arthropedics, Inc.	1987-11-02	53
K873651	BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375	Arthropedics, Inc.	1987-11-02	53
K863149	BOWEN PROBE	Bowen & Company, Inc.	1986-09-05	21
K841971	2.5MM & 4MM PROBE K841969-LABELING	Stainless Mfg., Inc.	1984-06-19	36
K840558	SHUTT PRECISION PROBES	Concept, Inc.	1984-04-25	77
K810294	LINE CADDY	Instranetics, Inc.	1981-02-26	22
K802951	I.M PROBES	Hogan & Hartson	1980-12-17	27
K802479	SURGICAL KNIVES & PROBES	Eder Instrument Co, Inc.	1980-10-31	24
K800729	PROBE	Stainless Mfg., Inc.	1980-04-08	7
K800444	GOLDEN RETRIEVERS OR SILVER RETRIEVERS	Instrument Makar, Inc.	1980-03-05	6
K800274	ACUFEX PROBES	Acufex Microsurgical, Inc.	1980-02-19	12

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