Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HBF — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
99 daysmedian FDA review time
296 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024-03-06 | 296 | 0 |
| K213228 | NeuroLine Disposable Cranial Perforator with Hudson end | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 2022-06-20 | 264 | 0 |
| K183581 | Codman Disposable Perforators | Integra Lifesciences Corp. | 2019-01-20 | 30 | 3 |
| K141455 | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | Micromar Ind. Com. , Ltd. | 2015-03-16 | 287 | 0 |
| K121253 | MERIDIAN CRANIAL PERFORATOR | Adeor Medical Technologies GmbH | 2012-07-17 | 83 | 0 |
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Stryker Ireland Ltd., Instruments Division | 2008-12-29 | 167 | 1 |
| K082637 | CRANIAL PERFORATOR | The Anspach Effort, Inc. | 2008-12-22 | 103 | 0 |
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | Codman & Shurtleff, Inc. | 2008-01-04 | 37 | 1 |
| K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | 2007-10-22 | 101 | 0 |
| K032970 | ACRA-CUT XPRESS 120 | Acra Cut, Inc. | 2003-12-08 | 76 | 0 |
| K982991 | ANSPACH ACCESS CRANIAL PERFORATOR | The Anspach Effort, Inc. | 1998-10-21 | 55 | 0 |
| K933894 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1993-12-10 | 122 | 0 |
| K924242 | DISPOSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1993-07-08 | 318 | 0 |
| K892866 | AUTOMATIC CRANIAL DRILL (PERFORATOR) | Acra Cut, Inc. | 1989-06-15 | 57 | 0 |
| K875019 | GHAJAR GUIDE SYSTEM FOR THE PERFORATOR | Neurodynamics, Inc. | 1988-01-22 | 49 | 0 |
| K833266 | ACRA-CUT | Acra Cut, Inc. | 1983-12-29 | 99 | 0 |
| K820087 | CODMAN * REUSABLE PERFORATOR | Codman & Shurtleff, Inc. | 1982-02-04 | 22 | 0 |
| K791101 | DISPOSABLE PERFORATORS, JACOBS, HUDSON | Codman & Shurtleff, Inc. | 1979-08-28 | 76 | 0 |
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