Gibeck, Inc.: FDA clearances and approvals
Gibeck, Inc. has 15 FDA 510(k) clearances (first 1990, latest 1997), across 6 product codes in 4 review panels. Median 510(k) review time: 47 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 7 | 7 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 | 3 |
| DWJ | System, Thermal Regulating | 2 | 2 |
| CBL | Absorbent, Carbon-Dioxide | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| IYT | System, Rebreathing, Radionuclide | 1 | 1 |
Review panels
- Anesthesiology (9)
- General Hospital (3)
- Cardiovascular (2)
- Radiology (1)
Most recent Gibeck, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965016 | ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) | CAH | 1997-12-02 | 351 |
| K964377 | THERMAL REGULATION SYSTEM BLANKET | DWJ | 1997-04-23 | 173 |
| K964382 | HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) | CAH | 1997-04-15 | 162 |
| K960511 | GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET | DWJ | 1997-01-13 | 343 |
| K954828 | ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT | CAH | 1996-05-02 | 195 |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | BYD | 1995-08-25 | 28 |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | BYD | 1995-08-25 | 31 |
| K952845 | HUMID-VENT TRACH-VENT | BYD | 1995-07-25 | 34 |
| K952844 | HUMID-VENT 2 | BYD | 1995-07-20 | 29 |
| K952750 | HUMID-VENT 1 | BYD | 1995-07-20 | 35 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gibeck, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Gibeck, Inc. have?
Gibeck, Inc. has 15 FDA 510(k) clearances (first 1990, latest 1997), across 6 product codes in 4 review panels.
How long does FDA take to clear Gibeck, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Gibeck, Inc.'s cleared 510(k)s is 47 days.
What devices does Gibeck, Inc. make?
Its most frequent FDA product codes are BYD (Condenser, Heat And Moisture (Artificial Nose), 7); CAH (Filter, Bacterial, Breathing-Circuit, 3); DWJ (System, Thermal Regulating, 2).
Has Gibeck, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Gibeck, Inc. Related entities may recall under other names.
Next steps
- See all 15 Gibeck, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYD, Gibeck, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.