Polaroid Corp.: FDA clearances and approvals
Polaroid Corp. has 5 FDA 510(k) clearances (first 1979, latest 1981), across 4 product codes in 2 review panels. Median 510(k) review time: 40 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 |
|---|---|---|---|
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | 2 | 2 |
| IWZ | Film, Radiographic | 1 | 1 |
| IXW | Processor, Radiographic-Film, Automatic | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Polaroid Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812542 | POLAROID INSTANT ENDOCAMERA | FEM | 1981-10-19 | 45 |
| K812089 | POLAROID RADIOGRAPHIC FILM CASSETTE | — | 1981-08-31 | 40 |
| K812088 | POLAROID RADIOGRAPHIC FILM PROCESSOR | IXW | 1981-08-31 | 40 |
| K811352 | POLAROID TPX RADIOGRAPHIC FILM | IWZ | 1981-06-18 | 35 |
| K792512 | POLAROID LAND CAMERA FOR ENDOSCOPY | FEM | 1979-12-20 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Polaroid Corp..
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 Polaroid Corp. have?
Polaroid Corp. has 5 FDA 510(k) clearances (first 1979, latest 1981), across 4 product codes in 2 review panels.
How long does FDA take to clear Polaroid Corp.'s 510(k)s?
The median time from FDA receipt to decision across Polaroid Corp.'s cleared 510(k)s is 40 days.
What devices does Polaroid Corp. make?
Its most frequent FDA product codes are FEM (Accessories, Photographic, For Endoscope (Exclude Light Sources), 2); IWZ (Film, Radiographic, 1); IXW (Processor, Radiographic-Film, Automatic, 1).
Has Polaroid Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Polaroid Corp. Related entities may recall under other names.
Next steps
- See all 5 Polaroid Corp. clearances with predicates and recalls
- Run predicate analysis for product code FEM, Polaroid Corp.'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.