Buckman Co., Inc.: FDA filings under this applicant name
FDA lists 111 510(k) clearances under the applicant name “Buckman Co., Inc.” (first 1983, latest 1998), across 66 product codes in 11 review panels. Median 510(k) review time under this name: 64 days. 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 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BXB | Exerciser, Powered | 8 | 8 |
| HWC | Screw, Fixation, Bone | 8 | 8 |
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 5 | 5 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 | 4 |
| JDW | Pin, Fixation, Threaded | 4 | 4 |
| HTN | Washer, Bolt Nut | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| GKZ | Counter, Differential Cell | 2 | 2 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
Plus 56 more product codes.
Review panels
- Orthopedic (61)
- Physical Medicine (13)
- General and Plastic Surgery (13)
- Cardiovascular (6)
- Obstetrics and Gynecology (4)
- Anesthesiology (2)
- Dental (2)
- Hematology (2)
- General Hospital (2)
- Neurology (2)
- Ear, Nose and Throat (1)
Most recent Buckman Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961320 | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM | HWC | 1998-06-25 | 811 |
| K974641 | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM | GEX | 1998-06-08 | 175 |
| K964252 | ORTHOCHUCK | GEY | 1997-05-27 | 215 |
| K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | MNH | 1997-01-16 | 737 |
| K960451 | WEBB-MORLEY SPINE SYSTEM | MNH | 1996-04-18 | 79 |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | MNH | 1996-01-25 | 328 |
| K945756 | IMAGN(TM) 2000 SYSTEM | GKZ | 1995-12-19 | 391 |
| K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT | GKZ | 1995-10-19 | 654 |
| K951117 | LIHTAN 532 LASER | GEX | 1995-10-18 | 222 |
| K942751 | VANGUARD SERIES GAS REGULATORS | CAN | 1995-02-09 | 244 |
101 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Buckman Co., Inc..
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.
- Buckman Consultants (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Buckman Co., Inc.?
FDA lists 111 510(k) clearances under the applicant name “Buckman Co., Inc.” (first 1983, latest 1998), across 66 product codes in 11 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Buckman Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Buckman Co., Inc. is 64 days.
Which FDA product codes appear under Buckman Co., Inc.?
The most frequent FDA product codes under this applicant name are BXB (Exerciser, Powered, 8); HWC (Screw, Fixation, Bone, 8); GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 111 Buckman Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Buckman Co., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.