Karlin Technology, Inc.: FDA clearances and approvals
Karlin Technology, Inc. has 17 FDA 510(k) clearances (first 1988, latest 1990), across 13 product codes in 4 review panels. Median 510(k) review time: 31 days.
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 |
|---|---|---|---|
| GAD | Retractor | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| LXH | Orthopedic Manual Surgical Instrument | 2 | 2 |
| BTX | Board, Arm (With Cover), Sterile | 1 | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HTS | Knife, Orthopedic | 1 | 1 |
| JAC | System, X-Ray, Film Marking, Radiographic | 1 | 1 |
Plus 3 more product codes.
Review panels
- Orthopedic (7)
- General and Plastic Surgery (7)
- Neurology (2)
- Radiology (1)
Most recent Karlin Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903969 | SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET | GAD | 1990-09-05 | 8 |
| K893203 | BONE SCREW | JDR | 1990-04-04 | 343 |
| K893201 | BONE PLATE | HRS | 1990-04-04 | 343 |
| K882525 | SPINAL MICROKNIFE | HTS | 1988-09-22 | 97 |
| K882519 | X-RAY MARKER | JAC | 1988-08-09 | 53 |
| K882520 | SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS | LWG | 1988-07-18 | 31 |
| K882073 | SPINAL NEEDLE | GDM | 1988-07-18 | 62 |
| K882524 | UNIVERSALLY ADJUSTABLE ARMBOARD | BTX | 1988-07-08 | 21 |
| K882077 | MICRODISCECTOMY CURRETTES | LXH | 1988-06-17 | 31 |
| K882072 | ORTHOPAEDIC AND SPINAL RING CURRETTES | JXH | 1988-06-17 | 31 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Karlin Technology, Inc..
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 Karlin Technology, Inc. have?
Karlin Technology, Inc. has 17 FDA 510(k) clearances (first 1988, latest 1990), across 13 product codes in 4 review panels.
How long does FDA take to clear Karlin Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Karlin Technology, Inc.'s cleared 510(k)s is 31 days.
What devices does Karlin Technology, Inc. make?
Its most frequent FDA product codes are GAD (Retractor, 3); KWP (Appliance, Fixation, Spinal Interlaminal, 2); LXH (Orthopedic Manual Surgical Instrument, 2).
Has Karlin Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Karlin Technology, Inc. Related entities may recall under other names.
Next steps
- See all 17 Karlin Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAD, Karlin Technology, Inc.'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.