Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hand Biomechanics Lab, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
184 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the H | Hand Biomechanics Lab, Inc. | 2025-10-15 | 107 | 0 |
| K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2022-11-14 | 89 | 0 |
| K181192 | PIP Fix | Hand Biomechanics Lab, Inc. | 2018-10-22 | 171 | 0 |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NO | Hand Biomechanics Lab, Inc. | 2008-01-09 | 133 | 0 |
| K033112 | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, M | Hand Biomechanics Lab, Inc. | 2003-11-05 | 36 | 0 |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, | Hand Biomechanics Lab, Inc. | 2003-06-10 | 111 | 0 |
| K992970 | DIGIT WIDGET | Hand Biomechanics Lab, Inc. | 1999-11-08 | 66 | 0 |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), M | Hand Biomechanics Lab, Inc. | 1999-02-12 | 60 | 0 |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Hand Biomechanics Lab, Inc. | 1994-12-22 | 184 | 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