Pharmaseal Laboratories: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pharmaseal Laboratories” (first 1976, latest 1980), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 2 | 2 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| HHD | Pad, Menstrual, Unscented | 1 | 1 |
| KYX | Dispenser, Liquid Medication | 1 | 1 |
Review panels
Most recent Pharmaseal Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800737 | DEBRISAN (DEXTRANOMER) PASTE | KOZ | 1980-08-04 | 124 |
| K801146 | SAMPLING KIT | CBT | 1980-06-04 | 22 |
| K800874 | PELVIC EXAM TRAY | HHD | 1980-05-08 | 21 |
| K800362 | FLUID DISPENSING SYSTEM | KYX | 1980-03-12 | 21 |
| K760469 | CLEANSING AGENT, NEW WOUND (DEBRISSU) | KOZ | 1976-12-16 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Pharmaseal Laboratories.
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.
- Pharmaseal Div., Baxter Healthcare Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pharmaseal Laboratories?
FDA lists 5 510(k) clearances under the applicant name “Pharmaseal Laboratories” (first 1976, latest 1980), across 4 product codes in 4 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 Pharmaseal Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharmaseal Laboratories is 22 days.
Which FDA product codes appear under Pharmaseal Laboratories?
The most frequent FDA product codes under this applicant name are KOZ (Beads, Hydrophilic, For Wound Exudate Absorption, 2); CBT (Arterial Blood Sampling Kit, 1); HHD (Pad, Menstrual, Unscented, 1).
Next steps
- See all 5 Pharmaseal Laboratories clearances with predicates and recalls
- Run predicate analysis for product code KOZ, Pharmaseal Laboratories'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.