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

Hogan & Hartson — Predicate Candidate Screening

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

98 daysmedian FDA review time

455 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K974168	COOPERSURGICAL INFRARED COAGULATOR	Hogan & Hartson	1998-01-23	79
K973849	BIOABSORBABLE BANKART TACK	Hogan & Hartson	1998-01-06	90
K973162	DUAL RADIATION TARGETING SYSTEM DRTS DRAPE	Hogan & Hartson	1997-11-20	90
K950169	RIBOSOMAL P EIA TEST SYSTEM	Hogan & Hartson	1996-05-23	492
K942389	TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES	Hogan & Hartson	1996-02-16	639
K946217	CARDIOLIPIN M EIA TEST SYSTEM	Hogan & Hartson	1996-01-24	399
K946215	CARDIOLIPIN G EIA TEST SYSTEM	Hogan & Hartson	1996-01-24	399
K946216	CARDIOLIPIN A EIA TEST SYSTEM	Hogan & Hartson	1996-01-24	399
K946186	CHAL-2500	Hogan & Hartson	1995-08-14	237
K941566	COMPUSPEAK	Hogan & Hartson	1995-06-30	455
K946218	MARDX ENA EIA TEST SYSTEM	Hogan & Hartson	1995-05-15	145
K950110	MARDX MITOCHONDRIA EIA TEST SYSTEM	Hogan & Hartson	1995-05-15	124
K950836	REDFIELD INFRARED COAGULATOR	Hogan & Hartson	1995-03-24	28
K942229	MOTIVATOR FTR 2000	Hogan & Hartson	1995-02-27	297
K941762	INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS	Hogan & Hartson	1995-02-22	317
K946336	MEGABEAM FIBER OPTIC DELIVERY SYSTEM	Hogan & Hartson	1995-02-10	43
K946101	EMERGENCY/ACCIDENT TROLLEY 550	Hogan & Hartson	1995-02-07	55
K945161	NORELCO CLEAN AIR SYSTEM CAS950	Hogan & Hartson	1994-11-28	42
K941417	VITAFLON PLUS/VASCULON	Hogan & Hartson	1994-10-06	197
K942627	454A ELECTROSURGICAL ANALYZER	Hogan & Hartson	1994-08-15	74
K941404	IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER	Hogan & Hartson	1994-06-29	98
K941819	LIQUID OXYGEN STORAGE SUBSYSTEM	Hogan & Hartson	1994-05-23	40
K941909	MEGA BEAM LATERAL FIRE	Hogan & Hartson	1994-05-23	34
K894973	RESPITRACE PLUS	Hogan & Hartson	1989-10-30	84
K810045	I.M. RETROGRADE BLADES	Hogan & Hartson	1981-02-12	35
K802951	I.M PROBES	Hogan & Hartson	1980-12-17	27

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