Walpak Co.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Walpak Co.” (first 1976, latest 1981), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 2 |
| FMF | Syringe, Piston | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
| KYZ | Syringe, Irrigating (Non Dental) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Walpak Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K803204 | IRRIGATION PISTON | FMF | 1981-01-21 | 35 |
| K803200 | IRRIGATION SET W/BULB SYRINGE | KYZ | 1981-01-21 | 35 |
| K803199 | SUTURE REMOVAL KIT | KDD | 1981-01-15 | 29 |
| K803198 | IRRIGATION SET W/PISTON SYRINGE | FMF | 1981-01-15 | 29 |
| K803201 | LEMON GLYCERINE SWABS | — | 1980-12-17 | 0 |
| K802083 | CATHETER INSERTION TRAY | KOD | 1980-09-16 | 18 |
| K791598 | CLOSED SYSTEM FOLEY CATHERIZATION PROCED | KOD | 1979-11-16 | 91 |
| K780124 | CATHETERIZATION PROCED. TRAY, URETHRAL | FCM | 1978-02-21 | 28 |
| K780123 | CATHETERIZATION PROCEDURE TRAY | FCM | 1978-02-21 | 28 |
| K770446 | SPONGES, LAPAROTOMY | EFQ | 1977-06-15 | 100 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Walpak Co..
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 Walpak Co.?
FDA lists 11 510(k) clearances under the applicant name “Walpak Co.” (first 1976, latest 1981), across 8 product codes in 3 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 Walpak Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Walpak Co. is 29 days.
Which FDA product codes appear under Walpak Co.?
The most frequent FDA product codes under this applicant name are FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 2); FMF (Syringe, Piston, 2); KOD (Catheter, Urological, 2).
Next steps
- See all 11 Walpak Co. clearances with predicates and recalls
- Run predicate analysis for product code FCM, Walpak Co.'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.