Icor AB: FDA clearances and approvals
Icor AB has 16 FDA 510(k) clearances (first 1986, latest 1996), across 6 product codes in 2 review panels. Median 510(k) review time: 78 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) | 9 | 9 |
| BZL | Computer, Oxygen-Uptake | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 | 1 |
| HME | Chair, Ophthalmic, Ac-Powered | 1 | 1 |
Review panels
- Anesthesiology (15)
- Ophthalmic (1)
Most recent Icor AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954402 | ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | CCK | 1996-05-22 | 245 |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | BYD | 1995-09-07 | 43 |
| K952325 | ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | CCK | 1995-07-31 | 74 |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | BYD | 1995-07-13 | 23 |
| K941987 | HEAT AND MOISTURE EXCHANGERS AND FILTERS | BYD | 1994-08-15 | 112 |
| K940041 | COLIBRI | BTR | 1994-07-27 | 204 |
| K941436 | AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF | BYD | 1994-06-08 | 76 |
| K925622 | FHB, FHB-T, FHBFLEX, FHBFLEX-T | BYD | 1993-05-26 | 201 |
| K914416 | BREATH-EASY, MODIFICATION | HME | 1992-06-23 | 272 |
| K904338 | ICOR HCH 4, ICOR HCH 7 | BYD | 1990-12-04 | 75 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Icor AB.
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 Icor AB have?
Icor AB has 16 FDA 510(k) clearances (first 1986, latest 1996), across 6 product codes in 2 review panels.
How long does FDA take to clear Icor AB's 510(k)s?
The median time from FDA receipt to decision across Icor AB's cleared 510(k)s is 78 days.
What devices does Icor AB make?
Its most frequent FDA product codes are BYD (Condenser, Heat And Moisture (Artificial Nose), 9); BZL (Computer, Oxygen-Uptake, 2); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2).
Has Icor AB had device recalls?
openFDA lists no recalls under a recalling firm name matching Icor AB. Related entities may recall under other names.
Next steps
- See all 16 Icor AB clearances with predicates and recalls
- Run predicate analysis for product code BYD, Icor AB'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.