L&K BIOMED Co., Ltd.: FDA clearances and approvals
L&K BIOMED Co., Ltd. has 58 FDA 510(k) clearances (first 2010, latest 2026), across 10 product codes in 1 review panel. Median 510(k) review time: 63 days. Since 2017 its median was 32 days, against 90 days for all cleared 510(k)s in the same product codes.
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 | 4 | 26 |
| 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, L&K BIOMED Co., Ltd.'s cleared 510(k)s took a median 32 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 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 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Review panels
- Orthopedic (58)
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 |
48 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does L&K BIOMED Co., Ltd. have?
L&K BIOMED Co., Ltd. has 58 FDA 510(k) clearances (first 2010, latest 2026), across 10 product codes in 1 review panel.
How long does FDA take to clear L&K BIOMED Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across L&K BIOMED Co., Ltd.'s cleared 510(k)s is 63 days. Since 2017: 32 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does L&K BIOMED Co., Ltd. make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 17); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 11); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 8).
Has L&K BIOMED Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching L&K BIOMED Co., Ltd. Related entities may recall under other names.
Next steps
- See all 58 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.