Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HFN — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
504 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | 2025-05-22 | 58 | 0 |
| K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUT | Clinical Innovations, Inc. | 1998-02-19 | 90 | 0 |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | Clinical Innovations, Inc. | 1997-11-24 | 54 | 0 |
| K961424 | INTRAN 500 | Utah Medical Products, Inc. | 1996-07-10 | 89 | 1 |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | 1996-04-17 | 173 | 0 |
| K955443 | INTRAN PLUS | Utah Medical Products, Inc. | 1996-02-20 | 84 | 1 |
| K920375 | DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER | Telos Medical Corp. | 1992-10-27 | 272 | 0 |
| K882224 | ULTRANS DISPOSABLE INTRAUTERINE | Telos Medical Corp. | 1989-10-12 | 504 | 0 |
| K893503 | SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS | Laurel Medical Corp. | 1989-06-12 | 38 | 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