Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prn Services, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
247 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943206 | VARIOUS TUBING | Prn Services, Inc. | 1995-03-09 | 247 | 0 |
| K902330 | E-Z FLO + SET | Prn Services, Inc. | 1990-09-21 | 120 | 0 |
| K897065 | PORT INFUSION SET (PIS) INFUSION SET (IS) | Prn Services, Inc. | 1990-02-16 | 58 | 0 |
| K882598 | 250 ML BAG W/Y INJECT. & 12 EXTENSION SET | Prn Services, Inc. | 1988-11-01 | 130 | 0 |
| K884053 | PRN PLUS + INFUSION SET | Prn Services, Inc. | 1988-10-31 | 35 | 0 |
| K875155 | 60 ML RESERVOIR BAG, ITEM #200 | Prn Services, Inc. | 1988-02-16 | 63 | 0 |
| K860222 | 70 ML RESERVOIR BAG AND ADMINISTRATION SETS | Prn Services, Inc. | 1986-06-09 | 138 | 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