KLS Martin L.P.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “KLS Martin L.P.” (first 2006, latest 2026), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 144 days. Since 2017 the median was 166 days, against 105 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 | 1 | 57 |
| 2013 | 0 | — |
| 2014 | 1 | 49 |
| 2015 | 2 | 164 |
| 2016 | 3 | 229 |
| 2017 | 3 | 163 |
| 2018 | 1 | 126 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 217 |
| 2023 | 1 | 270 |
| 2024 | 0 | — |
| 2025 | 1 | 168 |
| 2026 | 1 | 60 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name KLS Martin L.P. took a median 166 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 7 | 7 |
| JEY | Plate, Bone | 3 | 3 |
| MQN | External Mandibular Fixator And/Or Distractor | 3 | 3 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | 2 |
| PBJ | Cranial Distraction System | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
Review panels
- Orthopedic (9)
- Dental (7)
- Neurology (4)
Most recent KLS Martin L.P. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254162 | KLS Martin Ixos System | HRS | 2026-02-20 | 60 |
| K250620 | KLS Martin Ixos System | HRS | 2025-08-15 | 168 |
| K221938 | KLS Martin Pure Pectus System | HRS | 2023-03-28 | 270 |
| K220050 | KLS Martin IPS Distraction | MQN | 2022-08-11 | 217 |
| K173320 | KLS Martin L1 MMF System | JEY | 2018-02-23 | 126 |
| K163579 | KLS Martin Individual Patient Solutions | JEY | 2017-11-21 | 336 |
| K163315 | Internal Distraction - Sterile | PBJ | 2017-05-05 | 163 |
| K170124 | Level One Hand Plating System | HRS | 2017-03-09 | 55 |
| K161259 | KLS Martin Cannulated Headless Screws | HWC | 2016-12-19 | 229 |
| K161470 | Internal Distraction - Sterile | MQN | 2016-12-01 | 188 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named KLS Martin L.P..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under KLS Martin L.P.?
FDA lists 20 510(k) clearances under the applicant name “KLS Martin L.P.” (first 2006, latest 2026), across 8 product codes in 3 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 KLS Martin L.P.?
The median time from FDA receipt to decision across 510(k)s cleared under the name KLS Martin L.P. is 144 days. Since 2017: 166 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under KLS Martin L.P.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 7); JEY (Plate, Bone, 3); MQN (External Mandibular Fixator And/Or Distractor, 3).
Next steps
- See all 20 KLS Martin L.P. clearances with predicates and recalls
- Run predicate analysis for product code HRS, KLS Martin L.P.'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.