Poly Medicure Limited: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Poly Medicure Limited” (first 2023, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 180 days. Since 2017 the median was 180 days, against 205 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2023 | 3 | 129 |
| 2024 | 1 | 232 |
| 2025 | 1 | 72 |
| 2026 | 1 | 233 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Poly Medicure Limited took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 205 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 | 5 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Poly Medicure Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | FOZ | 2026-04-01 | 233 |
| K252677 | Polyshield Safety IV Catheters | FOZ | 2025-11-05 | 72 |
| K232234 | Nouvo Safety Set | FOZ | 2024-03-15 | 232 |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | FOZ | 2023-09-21 | 129 |
| K230616 | Polyguard and Polyshield Safety IV Catheters | FOZ | 2023-05-05 | 60 |
| K220312 | Polyfusion IV Administration Sets | FPA | 2023-04-12 | 434 |
Recalls
openFDA lists no recalls under a recalling firm named Poly Medicure Limited.
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.
- Poly-Medics,Inc. (5 510(k)s)
- Poly Vue Technolgies, Inc. (2 510(k)s)
- The Poly Group, Inc. (1 510(k)s)
- Poly- Med, Inc. (1 510(k)s)
- Poly-Med Splint Co. (1 510(k)s)
- Poly Medical Technologies, Inc. (1 510(k)s)
- Poly Shield Industries (Malaysia) Sdn. Bhd. (1 510(k)s)
- Poly-Tech Medical Device Research & Development (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Poly Medicure Limited?
FDA lists 6 510(k) clearances under the applicant name “Poly Medicure Limited” (first 2023, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Poly Medicure Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Poly Medicure Limited is 180 days. Since 2017: 180 days, versus 205 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Poly Medicure Limited?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 5); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 6 Poly Medicure Limited clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Poly Medicure Limited'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.