Atlas FDA

HBF

18 FDA 510(k) clearances · Product code

99 daysmedian time to decision
296 days90th percentile
18clearances measured

FDA profile

Official device name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4305
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 309 · 2022: 148 · 2023: 108 · 2024: 183 · 2025: 115 · 2026: 44
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
evoDrill Cranial Perforator (K231403)Evonos GmbH & Co. KG2024-03-06
NeuroLine Disposable Cranial Perforator with Hudson end (K213228)Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.2022-06-20
Codman Disposable Perforators (K183581)Integra Lifesciences Corp.2019-01-20
EASYDRILL AUTOSTOP CRANIAL PERFORATOR (K141455)Micromar Ind. Com. , Ltd.2015-03-16
MERIDIAN CRANIAL PERFORATOR (K121253)Adeor Medical Technologies GmbH2012-07-17
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT (K082010)Stryker Ireland Ltd., Instruments Division2008-12-29
CRANIAL PERFORATOR (K082637)The Anspach Effort, Inc.2008-12-22
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 (K073336)Codman & Shurtleff, Inc.2008-01-04
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 (K071931)Codman & Shurtleff, Inc.2007-10-22
ACRA-CUT XPRESS 120 (K032970)Acra Cut, Inc.2003-12-08
ANSPACH ACCESS CRANIAL PERFORATOR (K982991)The Anspach Effort, Inc.1998-10-21
DISPOSABLE PERFORATOR (K933894)Codman & Shurtleff, Inc.1993-12-10
DISPOSABLE PERFORATOR (K924242)Codman & Shurtleff, Inc.1993-07-08
AUTOMATIC CRANIAL DRILL (PERFORATOR) (K892866)Acra Cut, Inc.1989-06-15
GHAJAR GUIDE SYSTEM FOR THE PERFORATOR (K875019)Neurodynamics, Inc.1988-01-22
ACRA-CUT (K833266)Acra Cut, Inc.1983-12-29
CODMAN * REUSABLE PERFORATOR (K820087)Codman & Shurtleff, Inc.1982-02-04
DISPOSABLE PERFORATORS, JACOBS, HUDSON (K791101)Codman & Shurtleff, Inc.1979-08-28

Track HBF automatically

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