Hand Biomechanics Lab, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Hand Biomechanics Lab, Inc.” (first 1994, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 107 days. Since 2017 the median was 107 days, against 102 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 171 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 89 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 107 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hand Biomechanics Lab, Inc. took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JEC | Component, Traction, Invasive | 4 | 4 |
| HRX | Arthroscope | 2 | 2 |
| HTW | Bit, Drill | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Hand Biomechanics Lab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | HRX | 2025-10-15 | 107 |
| K222490 | HBL Blade Assembly | HRX | 2022-11-14 | 89 |
| K181192 | PIP Fix | JEC | 2018-10-22 | 171 |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | JEC | 2008-01-09 | 133 |
| K033112 | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS | KTT | 2003-11-05 | 36 |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | JEC | 2003-06-10 | 111 |
| K992970 | DIGIT WIDGET | JDW | 1999-11-08 | 66 |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | JEC | 1999-02-12 | 60 |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | HTW | 1994-12-22 | 184 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-09-14.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hand Innovations, Inc. (17 510(k)s)
- Hand Care, Inc., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hand Biomechanics Lab, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Hand Biomechanics Lab, Inc.” (first 1994, latest 2025), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hand Biomechanics Lab, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hand Biomechanics Lab, Inc. is 107 days. Since 2017: 107 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hand Biomechanics Lab, Inc.?
The most frequent FDA product codes under this applicant name are JEC (Component, Traction, Invasive, 4); HRX (Arthroscope, 2); HTW (Bit, Drill, 1).
Next steps
- See all 9 Hand Biomechanics Lab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JEC, Hand Biomechanics Lab, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.