Paladin Medical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Paladin Medical, Inc.” (first 1992, latest 1999), across 7 product codes in 7 review panels. Median 510(k) review time under this name: 222 days. 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 | 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 8 | 8 |
| DTE | Pulse-Generator, Pacemaker, External | 1 | 1 |
| FMW | Cover, Mattress (Medical Purposes) | 1 | 1 |
| HAM | Apparatus, Electrosurgical | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | 1 | 1 |
Review panels
- Obstetrics and Gynecology (8)
- Cardiovascular (1)
- General Hospital (1)
- Ophthalmic (1)
- Orthopedic (1)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Paladin Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993306 | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) | HAM | 1999-11-03 | 30 |
| K970347 | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM | DTE | 1997-08-29 | 214 |
| K971290 | STRATASYS FDM MEDMODELER SYSTEM | LLZ | 1997-06-20 | 74 |
| K964222 | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | LYL | 1996-12-20 | 59 |
| K950054 | ENDO-BEND(TM) SHAVER | HRX | 1995-06-29 | 174 |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | FMW | 1993-11-29 | 48 |
| K921015 | SHARPE ENDOSPONGE ASPIIRATOR | HET | 1993-05-21 | 444 |
| K915743 | SHARPE ENDOTENACULUM | HET | 1993-05-20 | 514 |
| K921888 | SHARPE ENDODISSECTOR | HET | 1992-10-20 | 182 |
| K915749 | SHARPE ENDOLIGATURE CARRIER | HET | 1992-10-20 | 302 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Paladin Medical, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Paladin Biomedical Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paladin Medical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Paladin Medical, Inc.” (first 1992, latest 1999), across 7 product codes in 7 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 Paladin Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paladin Medical, Inc. is 222 days.
Which FDA product codes appear under Paladin Medical, Inc.?
The most frequent FDA product codes under this applicant name are HET (Laparoscope, Gynecologic (And Accessories), 8); DTE (Pulse-Generator, Pacemaker, External, 1); FMW (Cover, Mattress (Medical Purposes), 1).
Next steps
- See all 14 Paladin Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HET, Paladin Medical, Inc.'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.