Atlas FDA

HQP

24 FDA 510(k) clearances · Product code

90 daysmedian time to decision
244 days90th percentile
24clearances measured

FDA profile

Official device name
Unit, Cautery, Thermal, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4115
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 1 · 2003: 3 · 2004: 3 · 2006: 2 · 2024: 23 · 2025: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) (K121441)Bovie Medical Corporation2012-07-20
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY (K083428)Fiab Spa2009-09-01
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (K062659)Kirwan Surgical Products, Inc.2007-03-09
SURGICAL MEDICAL DEVICE CAUTERY (K023506)Modern Medical Equipment Mfg., Ltd.2004-01-13
STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (K002547)Starion Instruments2000-10-20
CAUTERY GRASPER/DISSECTOR (K994019)Starion Instruments2000-01-20
THERMAL CAUTERY DEVICE, FORCEPS (K990728)Starion Instruments1999-06-03
OXBORO-MEDICAL CAUTERY TIP CLEANER (K952784)Oxboro Medical Intl., Inc.1995-07-13
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP (K945761)Aaron Medical Industries1995-04-10
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE (K945762)Aaron Medical Industries1995-02-07
LOW TEMPERATURE CAUTERY ELONGATED FINE TIP (K945763)Aaron Medical Industries1995-02-07
OPHTHALMIC CAUTERY (K945493)Aaron Medical Industries1995-01-30
ELECTROCAUTERY SYSTEM MODEL 1980 (K933079)Pmt Corp.1994-02-22
EFFNER CAUTERY INSTRUMENTS (K875260)Effner and Spreine Co.1988-06-06
REPLACE-A-TIP RECHARG. LOW TEMP. (K841325)Suncoast Medical Manufacturers, Inc.1984-05-09
REPLACE-A-TIP RECHARGEABLE HIGH TEMP (K841326)Suncoast Medical Manufacturers, Inc.1984-05-09
OPTHERM FINE TIP (K840425)Suncoast Medical Manufacturers, Inc.1984-05-09
OPTHERM EXTRA FINE TIP (K840426)Suncoast Medical Manufacturers, Inc.1984-05-09
XOMED THERMAL MYRINGOTOMY SYSTEM (K820157)Xomed, Inc.1982-03-02
MULTIPERFECTEMP CAUTERY (K810013)Medical Products Development, Inc.1981-04-23
REPLACABLE BATTERY PERFECTEMP CAUTERY (K810016)Medical Products Development, Inc.1981-04-23
MULTIMICRO SURGICAL CAUTERY (K810012)Medical Products Development, Inc.1981-04-23
PERFECTEMP OPHTHALMIC CAUTERY (K801078)Medical Products Development, Inc.1980-06-04
HOT TEMP CAUTERY (K771189)Edward Weck, Inc.1977-07-11

Track HQP automatically

Every clearance here is in the API, with alerts when new ones post.