Westmark, Sterile Packing Systems, Inc. (Sps): FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Westmark, Sterile Packing Systems, Inc. (Sps)” (first 1988, latest 1990), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 81 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 6 | 6 |
| KOD | Catheter, Urological | 3 | 3 |
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FPD | Tube, Feeding | 1 | 1 |
Plus 9 more product codes.
Review panels
- General Hospital (10)
- Gastroenterology and Urology (7)
- General and Plastic Surgery (5)
- Anesthesiology (4)
- Clinical Chemistry (1)
- Microbiology (1)
Most recent Westmark, Sterile Packing Systems, Inc. (Sps) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896800 | IRRIGATION TRAY | KYZ | 1990-05-24 | 174 |
| K896799 | PARACERVICAL/PUDENDAL TRAYS | CAZ | 1990-04-23 | 143 |
| K896559 | INFANT FEEDING TUBE | FPD | 1990-03-13 | 116 |
| K896794 | SPECIMEN CONTAINER | LIO | 1990-03-01 | 90 |
| K896806 | CATHETER PLUG/PROTECTOR | KNY | 1990-02-26 | 87 |
| K896798 | TRACHEOSTOMY TRAY | BTO | 1990-02-22 | 83 |
| K896797 | SUCTION CATHETER KIT | BSY | 1990-02-16 | 77 |
| K896215 | MERCY HIP/KNEE PACK | KKX | 1990-02-13 | 110 |
| K896804 | MANIFOLD | GCX | 1990-02-08 | 69 |
| K896563 | TUBING CONNECTORS | GCX | 1990-02-06 | 81 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Westmark, Sterile Packing Systems, Inc. (Sps).
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.
- Westmark Hospital Supplies (7 510(k)s)
- Westmark Enterprises, Inc. (3 510(k)s)
- Westmark Sps, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Westmark, Sterile Packing Systems, Inc. (Sps)?
FDA lists 28 510(k) clearances under the applicant name “Westmark, Sterile Packing Systems, Inc. (Sps)” (first 1988, latest 1990), across 19 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 Westmark, Sterile Packing Systems, Inc. (Sps)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Westmark, Sterile Packing Systems, Inc. (Sps) is 81 days.
Which FDA product codes appear under Westmark, Sterile Packing Systems, Inc. (Sps)?
The most frequent FDA product codes under this applicant name are GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered, 6); KOD (Catheter, Urological, 3); BSY (Catheters, Suction, Tracheobronchial, 2).
Next steps
- See all 28 Westmark, Sterile Packing Systems, Inc. (Sps) clearances with predicates and recalls
- Run predicate analysis for product code GCX, Westmark, Sterile Packing Systems, Inc. (Sps)'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.