Pollak (Intl.), Ltd.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Pollak (Intl.), Ltd.” (first 1980, latest 2000), across 23 product codes in 6 review panels. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 4 | 4 |
| FMC | Patient Examination Glove | 2 | 2 |
| FQM | Bandage, Elastic | 2 | 2 |
| KDD | Kit, Surgical Instrument, Disposable | 2 | 2 |
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | 2 | 2 |
| FKK | Clamp, Line | 1 | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 1 |
| FMH | Container, Specimen, Sterile | 1 | 1 |
| FRQ | Tube, Levine | 1 | 1 |
Plus 13 more product codes.
Review panels
- General and Plastic Surgery (12)
- General Hospital (11)
- Gastroenterology and Urology (3)
- Microbiology (1)
- Obstetrics and Gynecology (1)
- Physical Medicine (1)
Most recent Pollak (Intl.), Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000227 | UMBICUT | HFW | 2000-04-27 | 94 |
| K810049 | PEDICAT* | KMJ | 1981-04-21 | 98 |
| K810050 | VECAFIX* | KGX | 1981-03-26 | 72 |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | FLN | 1980-10-31 | 72 |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | FKK | 1980-10-31 | 72 |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | KDD | 1980-10-10 | 51 |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | FRQ | 1980-09-26 | 37 |
| K802022 | STERILE GUAZE SWABS CAT.#301-420 | EFQ | 1980-09-16 | 27 |
| K802021 | PEDIBAND CAT.#195-197 | NAD | 1980-09-16 | 27 |
| K802019 | SUTURE REMOVAL SET CAT.#906 | KDD | 1980-09-16 | 27 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pollak (Intl.), Ltd..
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 Pollak (Intl.), Ltd.?
FDA lists 31 510(k) clearances under the applicant name “Pollak (Intl.), Ltd.” (first 1980, latest 2000), across 23 product codes in 6 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 Pollak (Intl.), Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pollak (Intl.), Ltd. is 27 days.
Which FDA product codes appear under Pollak (Intl.), Ltd.?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 4); FMC (Patient Examination Glove, 2); FQM (Bandage, Elastic, 2).
Next steps
- See all 31 Pollak (Intl.), Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Pollak (Intl.), Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.