KLS-Martin L.P.: FDA filings under this applicant name
FDA lists 59 510(k) clearances under the applicant name “KLS-Martin L.P.” (first 1994, latest 2026), across 18 product codes in 4 review panels. Median 510(k) review time under this name: 112 days. Since 2017 the median was 218 days, against 135 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 | 248 |
| 2013 | 1 | 230 |
| 2014 | 1 | 199 |
| 2015 | 0 | — |
| 2016 | 1 | 125 |
| 2017 | 0 | — |
| 2018 | 2 | 124 |
| 2019 | 3 | 218 |
| 2020 | 2 | 136 |
| 2021 | 0 | — |
| 2022 | 3 | 494 |
| 2023 | 3 | 267 |
| 2024 | 3 | 98 |
| 2025 | 3 | 238 |
| 2026 | 2 | 152 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name KLS-Martin L.P. took a median 218 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 135 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JEY | Plate, Bone | 16 | 16 |
| HRS | Plate, Fixation, Bone | 11 | 11 |
| MQN | External Mandibular Fixator And/Or Distractor | 10 | 10 |
| DZL | Screw, Fixation, Intraosseous | 3 | 3 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 3 | 3 |
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 2 | 2 |
| PPT | Cranial Surgical Planning And Instrument Guides | 2 | 2 |
| DYX | Lock, Wire, And Ligature, Intraoral | 1 | 1 |
| ELE | Implant, Subperiosteal | 1 | 1 |
Plus 8 more product codes.
Review panels
- Dental (36)
- Orthopedic (13)
- Neurology (9)
- General and Plastic Surgery (1)
Most recent KLS-Martin L.P. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | JEY | 2026-08-17 | 213 |
| K253660 | KLS Martin Pure Pectus System | HRS | 2026-02-20 | 92 |
| K250988 | KLS Martin Pure Pectus System | HRS | 2025-12-11 | 255 |
| K250865 | KLS Martin IPS Forearm System | HRS | 2025-11-14 | 238 |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE | GXN | 2025-11-10 | 88 |
| K233721 | KLS Martin Drill-Free MMF Screw | DZL | 2024-09-17 | 301 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | JEY | 2024-08-16 | 98 |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | HRS | 2024-07-12 | 88 |
| K230211 | CranioXpand | PBJ | 2023-11-21 | 299 |
| K222624 | KLS Martin LINOS Wrist System | HRS | 2023-05-25 | 267 |
49 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 59 510(k) clearances under the applicant name “KLS-Martin L.P.” (first 1994, latest 2026), across 18 product codes in 4 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 112 days. Since 2017: 218 days, versus 135 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 JEY (Plate, Bone, 16); HRS (Plate, Fixation, Bone, 11); MQN (External Mandibular Fixator And/Or Distractor, 10).
Next steps
- See all 59 KLS-Martin L.P. clearances with predicates and recalls
- Run predicate analysis for product code JEY, 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.