Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gibeck, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
343 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965016 | ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212 | Gibeck, Inc. | 1997-12-02 | 351 | 6 |
| K964377 | THERMAL REGULATION SYSTEM BLANKET | Gibeck, Inc. | 1997-04-23 | 173 | 0 |
| K964382 | HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER C | Gibeck, Inc. | 1997-04-15 | 162 | 0 |
| K960511 | GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET | Gibeck, Inc. | 1997-01-13 | 343 | 0 |
| K954828 | ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT | Gibeck, Inc. | 1996-05-02 | 195 | 0 |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Gibeck, Inc. | 1995-08-25 | 28 | 0 |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Gibeck, Inc. | 1995-08-25 | 31 | 0 |
| K952845 | HUMID-VENT TRACH-VENT | Gibeck, Inc. | 1995-07-25 | 34 | 0 |
| K952844 | HUMID-VENT 2 | Gibeck, Inc. | 1995-07-20 | 29 | 0 |
| K952750 | HUMID-VENT 1 | Gibeck, Inc. | 1995-07-20 | 35 | 0 |
| K952084 | HUMID-VENT FILTER PEDI | Gibeck, Inc. | 1995-06-12 | 40 | 0 |
| K951856 | HUMID-VENT MICRO | Gibeck, Inc. | 1995-06-07 | 47 | 0 |
| K914747 | XENON CIRCUIT | Gibeck, Inc. | 1992-02-27 | 128 | 0 |
| K900979 | GAS SAMPLING NASAL CANNULA | Gibeck, Inc. | 1990-03-16 | 14 | 0 |
| K897171 | DISPOSABLE CO2 ABSORBER/E | Gibeck, Inc. | 1990-03-13 | 75 | 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