Kronner Medical: FDA clearances and approvals
Kronner Medical has 7 FDA 510(k) clearances (first 1987, latest 1990), across 5 product codes in 2 review panels. Median 510(k) review time: 53 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| HWT | Template | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 1 |
Review panels
- Orthopedic (6)
- Anesthesiology (1)
Most recent Kronner Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894228 | KRONNER SPHERICAL CUTTERS | HWT | 1990-07-23 | 399 |
| K895171 | BLOOD GAS SAFETY SYRINGE | CBT | 1989-11-07 | 89 |
| K895173 | SKELETAL FIXATION PIN | JDW | 1989-09-12 | 33 |
| K895172 | KRONNER SACRAL PIN GUIDE | LXH | 1989-09-12 | 33 |
| K871248 | KRONNER COLLES-FOREARM EXTERNAL FIXATION | KTT | 1987-06-03 | 65 |
| K871249 | KRONNER BI-PLANER TIBIA EXTERNAL FIXATION | KTT | 1987-05-22 | 53 |
| K871247 | KRONNER UNIVERSAL FRAME EXTERNAL FIXATION | KTT | 1987-05-22 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Kronner Medical.
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 Kronner Medical have?
Kronner Medical has 7 FDA 510(k) clearances (first 1987, latest 1990), across 5 product codes in 2 review panels.
How long does FDA take to clear Kronner Medical's 510(k)s?
The median time from FDA receipt to decision across Kronner Medical's cleared 510(k)s is 53 days.
What devices does Kronner Medical make?
Its most frequent FDA product codes are KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 3); CBT (Arterial Blood Sampling Kit, 1); HWT (Template, 1).
Has Kronner Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Kronner Medical. Related entities may recall under other names.
Next steps
- See all 7 Kronner Medical clearances with predicates and recalls
- Run predicate analysis for product code KTT, Kronner Medical'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.