Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Superior Plastic Products Corp. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
91 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851981 | NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. | Superior Plastic Products Corp. | 1985-06-18 | 42 | 0 |
| K843975 | 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE | Superior Plastic Products Corp. | 1984-11-20 | 40 | 0 |
| K841945 | ENTERAL FEEDING BOTTLE | Superior Plastic Products Corp. | 1984-07-26 | 76 | 0 |
| K841630 | ENTERAL NUTRITION PUMP | Superior Plastic Products Corp. | 1984-06-07 | 49 | 0 |
| K840323 | SILICONE SUCTION & IRRIGATION DRAIN | Superior Plastic Products Corp. | 1984-04-25 | 91 | 0 |
| K840324 | SILICONE SUMP DRAIN 20 & 40 FRENCH | Superior Plastic Products Corp. | 1984-04-25 | 91 | 0 |
| K841480 | INFECTION CONTROL VALVE | Superior Plastic Products Corp. | 1984-04-25 | 16 | 0 |
| K833687 | DISPOS. ENTERIC FEEDING TUBES W/SAFE-T | Superior Plastic Products Corp. | 1984-03-02 | 123 | 0 |
| K833947 | SUPERIOR ENTERNAL FEEDING SYSTEM | Superior Plastic Products Corp. | 1984-02-04 | 81 | 0 |
| K820460 | 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION | Superior Plastic Products Corp. | 1982-03-08 | 17 | 0 |
| K812312 | STERILE WATER 4OZ. | Superior Plastic Products Corp. | 1981-11-13 | 88 | 0 |
| K761191 | 4 1/2 OZ. GRADUATED SPECIMEN CONTAINER | Superior Plastic Products Corp. | 1977-02-28 | 84 | 0 |
| K761192 | DRESSING CHANGE KIT | Superior Plastic Products Corp. | 1977-02-28 | 84 | 0 |
| K761193 | SUTURE REMOVAL KIT | Superior Plastic Products Corp. | 1977-01-12 | 37 | 1 |
| K761190 | TRACHEOSTOMY CARE KIT | Superior Plastic Products Corp. | 1976-12-16 | 10 | 1 |
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