Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Westmark, Sterile Packing Systems, Inc. (Sps) · Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
116 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896800 | IRRIGATION TRAY | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-05-24 | 174 | 0 |
| K896799 | PARACERVICAL/PUDENDAL TRAYS | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-04-23 | 143 | 0 |
| K896559 | INFANT FEEDING TUBE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-03-13 | 116 | 0 |
| K896794 | SPECIMEN CONTAINER | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-03-01 | 90 | 0 |
| K896806 | CATHETER PLUG/PROTECTOR | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-26 | 87 | 0 |
| K896798 | TRACHEOSTOMY TRAY | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-22 | 83 | 0 |
| K896797 | SUCTION CATHETER KIT | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-16 | 77 | 0 |
| K896215 | MERCY HIP/KNEE PACK | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-13 | 110 | 0 |
| K896804 | MANIFOLD | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-08 | 69 | 0 |
| K896558 | YANKAUER SUCTION TUBE-RIGID TYPE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896556 | UNIVERSAL POOLE SUCTION TUBE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896563 | TUBING CONNECTORS | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896557 | YANKAUER SUCTION TUBE-FLEXIBLE TYPE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896562 | STOPCOCK | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-06 | 81 | 0 |
| K896561 | EXTENSION SET | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-02-01 | 76 | 0 |
| K896212 | URETHRAL CATHETERIZATION TRAYS | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-24 | 90 | 0 |
| K896560 | MUCOUS TRAP | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-22 | 66 | 0 |
| K896211 | CYSTOSCOPY/IRRIGATION SET | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-18 | 84 | 0 |
| K896213 | Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-18 | 84 | 0 |
| K896208 | CYSTO PUMP DRAINAGE BAG | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-18 | 84 | 0 |
| K896210 | GASTRIC SUMP TUBE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-01-18 | 84 | 0 |
| K896801 | LAP SPONGE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 | 26 | 0 |
| K896792 | SURGICAL SKIN MARKER | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 | 26 | 0 |
| K896802 | MAGNET PAD | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 | 26 | 0 |
| K896803 | CLOSED WOUND RESERVOIR | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 | 26 | 0 |
| K883472 | CLOSED WOUND SUCTION DEVICE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-10-18 | 63 | 0 |
| K883474 | THORACIC CATHETERS | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-09-13 | 28 | 0 |
| K883473 | SURGICAL CONNECTING TUBES | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-08-25 | 9 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda