Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gesco Intl., Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
188 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | Gesco Intl., Inc. | 1995-12-15 | 85 | 0 |
| K940953 | UMBILI-CATH-S | Gesco Intl., Inc. | 1994-08-02 | 154 | 0 |
| K940870 | UMBILI-CATH | Gesco Intl., Inc. | 1994-08-02 | 158 | 0 |
| K940952 | UMBILI-CATH-S-DL | Gesco Intl., Inc. | 1994-07-29 | 150 | 0 |
| K941672 | URI-CATH CATHETER | Gesco Intl., Inc. | 1994-05-16 | 41 | 0 |
| K941232 | THORA-CATH | Gesco Intl., Inc. | 1994-05-11 | 57 | 0 |
| K940871 | UMBILI-CATH-P | Gesco Intl., Inc. | 1994-04-29 | 63 | 0 |
| K931989 | VENTRI-CATH | Gesco Intl., Inc. | 1993-07-21 | 90 | 0 |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Gesco Intl., Inc. | 1993-06-07 | 188 | 0 |
| K923591 | PALA-NATE | Gesco Intl., Inc. | 1993-03-16 | 239 | 0 |
| K915167 | GESCO PER-Q-CATH CATHETER INTRODUCER | Gesco Intl., Inc. | 1992-01-27 | 73 | 0 |
| K911326 | OBSTETRICAL VACUUM CUP | Gesco Intl., Inc. | 1991-08-14 | 141 | 0 |
| K910652 | SPINAL TAP NEEDLE | Gesco Intl., Inc. | 1991-07-24 | 160 | 0 |
| K911607 | GESCO UMBILI-CATH | Gesco Intl., Inc. | 1991-06-11 | 62 | 0 |
| K911215 | GESCO PER-Q-CATH NEEDLE | Gesco Intl., Inc. | 1991-06-06 | 79 | 0 |
| K910622 | GESCO PER-Q-CATH REPAIR KIT | Gesco Intl., Inc. | 1991-03-29 | 45 | 0 |
| K895942 | GESCO DUAL LUMEN PER-Q-CATH-DL | Gesco Intl., Inc. | 1990-07-02 | 264 | 0 |
| K896041 | GESCO DUAL LUMEN UMBILICATH II-DL | Gesco Intl., Inc. | 1990-04-17 | 182 | 0 |
| K882647 | GESCO CATHETERIZATION TRAY | Gesco Intl., Inc. | 1988-09-09 | 74 | 0 |
| K872221 | DIALY-NATE SET & DIALY-NATE CATHETER | Gesco Intl., Inc. | 1987-10-13 | 126 | 0 |
| K870962 | GESCO ASPIRATOR | Gesco Intl., Inc. | 1987-05-22 | 73 | 0 |
| K861090 | NUTRI-CATH - FEEDING TUBE | Gesco Intl., Inc. | 1986-06-18 | 86 | 0 |
| K852490 | URI-CATH SYSTEM | Gesco Intl., Inc. | 1985-11-05 | 146 | 0 |
| K851385 | THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE | Gesco Intl., Inc. | 1985-05-23 | 44 | 0 |
| K831845 | PER-Q-CATH TRAY | Gesco Intl., Inc. | 1983-08-24 | 77 | 0 |
| K772288 | CATHETER, CHOLANGIOGRAM, OPERATIVE | Gesco Intl., Inc. | 1978-01-30 | 49 | 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