L&K BIOMED Co., Ltd.: FDA filings under this applicant name
FDA lists 59 510(k) clearances under 2 spellings of the applicant name “L&K BIOMED Co., Ltd.” (first 2010, latest 2026), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 65 days. Since 2017 the median was 33 days, against 89 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 | 8 | 63 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 7 | 130 |
| 2016 | 5 | 94 |
| 2017 | 1 | 24 |
| 2018 | 5 | 28 |
| 2019 | 3 | 181 |
| 2020 | 5 | 216 |
| 2021 | 0 | — |
| 2022 | 2 | 80 |
| 2023 | 8 | 28 |
| 2024 | 2 | 32 |
| 2025 | 3 | 32 |
| 2026 | 6 | 34 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name L&K BIOMED Co., Ltd. took a median 33 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 17 | 17 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 11 | 11 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 8 | 8 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 5 | 5 |
| NKG | Posterior Cervical Screw System | 4 | 4 |
| OUR | Sacroiliac Joint Fixation | 4 | 4 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (59)
Most recent L&K BIOMED Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262489 | BluEX Cervical Expandable Cage System | ODP | 2026-08-18 | 29 |
| K260840 | BluEX Cervical Expandable Cage System | ODP | 2026-05-16 | 61 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | KWQ | 2026-05-06 | 33 |
| K261130 | AccelFix Spinal Fixation System | NKB | 2026-05-05 | 29 |
| K260448 | CastleLoc Pectus Bar System | HRS | 2026-03-19 | 36 |
| K251940 | PathLoc Lumbar Plate System | KWQ | 2026-03-03 | 252 |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | MAX | 2025-07-08 | 32 |
| K250892 | CastleLoc Pectus Bar System | HRS | 2025-04-25 | 31 |
| K243357 | CastleLoc Pectus Bar System | HRS | 2025-02-27 | 121 |
| K242829 | BluEX Lumbar Expandable Cage System | MAX | 2024-10-23 | 34 |
49 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named L&K BIOMED Co., Ltd..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- L&K BIOMED Co., Ltd. (58)
- L and K Biomed Corporation Limited (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under L&K BIOMED Co., Ltd.?
FDA lists 59 510(k) clearances under 2 spellings of the applicant name “L&K BIOMED Co., Ltd.” (first 2010, latest 2026), across 11 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 L&K BIOMED Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name L&K BIOMED Co., Ltd. is 65 days. Since 2017: 33 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under L&K BIOMED Co., Ltd.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 17); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 11); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 8).
Next steps
- See all 59 L&K BIOMED Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NKB, L&K BIOMED Co., Ltd.'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.