Kinetic Medical Products: FDA clearances and approvals
Kinetic Medical Products has 63 FDA 510(k) clearances (first 1989, latest 1989), across 33 product codes in 7 review panels. Median 510(k) review time: 9 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 |
|---|---|---|---|
| HTD | Forceps | 14 | 14 |
| HXD | Clamp | 4 | 4 |
| EMF | Knife, Surgical | 3 | 3 |
| GAD | Retractor | 3 | 3 |
| GDF | Guide, Needle, Surgical | 3 | 3 |
| GEG | Elevator, Surgical, General & Plastic Surgery | 3 | 3 |
| HCZ | Forceps, Surgical, Gynecological | 3 | 3 |
| HRR | Scissors, Orthopedic, Surgical | 3 | 3 |
| EMH | Forceps, Rongeur, Surgical | 2 | 2 |
| LRW | Scissors, General, Surgical | 2 | 2 |
Plus 23 more product codes.
Review panels
- General and Plastic Surgery (38)
- Obstetrics and Gynecology (14)
- Orthopedic (4)
- Dental (3)
- Neurology (2)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
Most recent Kinetic Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890385 | MIDWIFERY/OBSTETRICAL FORCEPS | HDA | 1989-03-01 | 37 |
| K890387 | MALLEABLE PLACENTA CURETTE | HEX | 1989-02-27 | 35 |
| K890382 | COMPRESSION FORCEPS | HFW | 1989-02-27 | 35 |
| K890380 | CERVICAL BIOPSY FORCEPS | HFB | 1989-02-27 | 35 |
| K890376 | VAGINAL SPECULUM | HFD | 1989-02-27 | 35 |
| K890383 | HYSTERECTOMY FORCEPS | HCZ | 1989-02-16 | 24 |
| K890216 | MICROSURGICAL KERATOME | GZX | 1989-02-16 | 29 |
| K890389 | UMBILICAL SCISSORS | HDJ | 1989-02-13 | 21 |
| K890388 | CEPHALOTOMY SCISSORS | KNB | 1989-02-13 | 21 |
| K890386 | PLACENTA AND OVUM FORCEPS | HCZ | 1989-02-13 | 21 |
53 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kinetic Medical Products.
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 Kinetic Medical Products have?
Kinetic Medical Products has 63 FDA 510(k) clearances (first 1989, latest 1989), across 33 product codes in 7 review panels.
How long does FDA take to clear Kinetic Medical Products's 510(k)s?
The median time from FDA receipt to decision across Kinetic Medical Products's cleared 510(k)s is 9 days.
What devices does Kinetic Medical Products make?
Its most frequent FDA product codes are HTD (Forceps, 14); HXD (Clamp, 4); EMF (Knife, Surgical, 3).
Has Kinetic Medical Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Kinetic Medical Products. Related entities may recall under other names.
Next steps
- See all 63 Kinetic Medical Products clearances with predicates and recalls
- Run predicate analysis for product code HTD, Kinetic Medical Products'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.