Gibeck Respiration: FDA clearances and approvals
Gibeck Respiration has 6 FDA 510(k) clearances (first 1987, latest 1988), across 1 product code in 1 review panel. Median 510(k) review time: 61 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) | 6 | 6 |
Review panels
- Anesthesiology (6)
Most recent Gibeck Respiration 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881657 | HUMID-VENT FILTER | BYD | 1988-06-24 | 70 |
| K881656 | HUMID-VENT 2 S FLEX | BYD | 1988-06-16 | 62 |
| K881644 | HUMID-VENT 2 S | BYD | 1988-06-10 | 56 |
| K873768 | HUMID-VENT(R) 2 PORT | BYD | 1987-11-24 | 69 |
| K873767 | HUMID-VENT(R) MINI | BYD | 1987-11-06 | 51 |
| K872153 | STOM-VENT | BYD | 1987-08-03 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Gibeck Respiration.
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 Respiration have?
Gibeck Respiration has 6 FDA 510(k) clearances (first 1987, latest 1988), across 1 product code in 1 review panel.
How long does FDA take to clear Gibeck Respiration's 510(k)s?
The median time from FDA receipt to decision across Gibeck Respiration's cleared 510(k)s is 61 days.
What devices does Gibeck Respiration make?
Its most frequent FDA product codes are BYD (Condenser, Heat And Moisture (Artificial Nose), 6).
Has Gibeck Respiration had device recalls?
openFDA lists no recalls under a recalling firm name matching Gibeck Respiration. Related entities may recall under other names.
Next steps
- See all 6 Gibeck Respiration clearances with predicates and recalls
- Run predicate analysis for product code BYD, Gibeck Respiration'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.