Polymer Technology Corp.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under 2 spellings of the applicant name “Polymer Technology Corp.” (first 1983, latest 2001), across 13 product codes in 6 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 8 | 8 |
| CGA | Glucose Oxidase, Glucose | 5 | 5 |
| LPN | Accessories, Soft Lens Products | 4 | 4 |
| KER | Container, Embedding | 2 | 2 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 | 1 |
| GAX | Tourniquet, Nonpneumatic | 1 | 1 |
| IDL | Microtome, Accessories | 1 | 1 |
| IDZ | Cassettes, Tissue | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 1 | 1 |
Plus 3 more product codes.
Review panels
- Ophthalmic (15)
- Clinical Chemistry (5)
- Pathology (4)
- General Hospital (2)
- Microbiology (1)
- General and Plastic Surgery (1)
Most recent Polymer Technology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011945 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION | HQD | 2001-09-12 | 83 |
| K003933 | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY | MUW | 2001-02-16 | 58 |
| K003932 | BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY | HQD | 2001-02-16 | 58 |
| K002025 | RIGID GAS PERMEABLE CONTACT LENS | HQD | 2000-10-31 | 120 |
| K001960 | RIGID GAS PERMEABLE CONTACT LENS | HQD | 2000-08-28 | 62 |
| K000795 | RIGID GAS PERMEABLE CONTACT LENS | HQD | 2000-05-26 | 74 |
| K980133 | BAUSCH & LOMB WETTING AND SOAKING SOLUTION | LPN | 1998-03-11 | 55 |
| K974466 | BOSTON ADVANCE CLEANER | MRC | 1998-02-19 | 85 |
| K973217 | BOSTON LIQUID ENZYMATIC CLEANER | LPN | 1997-11-24 | 89 |
| K970698 | BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS | HQD | 1997-05-06 | 70 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Polymer Technology Corp..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Polymer Technology Corp. (23)
- Polymer Technology (5)
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.
- Polymer Technology Systems, Inc. (27 510(k)s)
- Polymer Technology Intl. (6 510(k)s)
- Polymer Technology Div. Wilmington Partners, L.P. (3 510(k)s)
- Polymer Technology Systems, Inc. D/B/A Pts Diagnostics (3 510(k)s)
- Polymer Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polymer Technology Corp.?
FDA lists 28 510(k) clearances under 2 spellings of the applicant name “Polymer Technology Corp.” (first 1983, latest 2001), across 13 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 Polymer Technology Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polymer Technology Corp. is 60 days.
Which FDA product codes appear under Polymer Technology Corp.?
The most frequent FDA product codes under this applicant name are HQD (Lens, Contact (Other Material) - Daily, 8); CGA (Glucose Oxidase, Glucose, 5); LPN (Accessories, Soft Lens Products, 4).
Next steps
- See all 28 Polymer Technology Corp. clearances with predicates and recalls
- Run predicate analysis for product code HQD, Polymer Technology Corp.'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.