Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HBG — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
221 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252696 | LEGACY | Phasor Health, LLC | 2025-11-21 | 86 | 0 |
| K153587 | Taps for Resorbable Screws | Synthes (USA) Products, LLC | 2017-01-18 | 399 | 0 |
| K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017-01-12 | 90 | 0 |
| K160129 | MRII Cranial Drill and Accessories | Mri Interventions, Inc. | 2016-03-26 | 66 | 0 |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5 | Mri Interventions, Inc. | 2015-07-08 | 30 | 0 |
| K122456 | MRII CRAINIAL DRILL | Mri Interventions, Inc. | 2013-03-22 | 221 | 0 |
| K022712 | HAND DRILL, MODEL 11-9901-7 | Medical Design, LLC | 2002-11-12 | 90 | 0 |
| K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES | Medtronic Xomed, Inc. | 2002-10-18 | 88 | 0 |
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | Clinical Neuro Systems, LLC | 1996-06-05 | 77 | 39 |
| K932402 | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | 1993-08-05 | 106 | 0 |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | Pudenz-Schulte Medical Research Corp. | 1991-12-30 | 19 | 1 |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | Pudenz-Schulte Medical Research Corp. | 1990-10-03 | 16 | 0 |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Ruggles Corp. | 1990-09-20 | 85 | 1 |
| K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON | Zinnanti Surgical Instruments, Inc. | 1989-05-05 | 24 | 0 |
| K875018 | GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | 1988-01-28 | 55 | 0 |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Solway, Inc. | 1987-12-30 | 28 | 0 |
| K862160 | CAMINO HAND DRILL - MODEL 030 | Camino Laboratories, Inc. | 1986-07-18 | 42 | 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