Ohmeda Medical: FDA clearances and approvals
Ohmeda Medical has 119 FDA 510(k) clearances (first 1984, latest 2013), plus 1 De Novo decision, across 41 product codes in 5 review panels. Median 510(k) review time: 79 days. openFDA lists 13 product recalls by a recalling firm named Ohmeda Medical.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 104 |
| 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 17 | 17 |
| FMZ | Incubator, Neonatal | 15 | 15 |
| CBK | Ventilator, Continuous, Facility Use | 10 | 10 |
| FMT | Warmer, Infant Radiant | 10 | 10 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 | 6 |
| DQA | Oximeter | 5 | 5 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 4 | 4 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 4 | 4 |
| FMG | Stopcock, I.V. Set | 4 | 4 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 3 | 3 |
Plus 31 more product codes.
Review panels
- Anesthesiology (68)
- General Hospital (40)
- Cardiovascular (8)
- Clinical Chemistry (2)
- Neurology (1)
Most recent Ohmeda Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123309 | GIRAFFE AND PANDA WARMERS | FMT | 2013-02-05 | 104 |
| K101788 | GIRAFFE OMNIBED | FMZ | 2010-07-21 | 26 |
| K101778 | GIRAFFE INCUBATOR | FMZ | 2010-07-21 | 26 |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | FMT | 2009-04-16 | 30 |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | FMT | 2007-08-27 | 24 |
| K070377 | GIRAFFE AND PANDA WARMER | FMT | 2007-07-11 | 153 |
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | BTM | 2007-04-20 | 85 |
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | BTL | 2007-04-20 | 88 |
| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | FMZ | 2004-04-16 | 93 |
| K020547 | OHMEDA MEDICAL GIRAFFE INCUBATOR | FMZ | 2002-05-09 | 79 |
109 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN000001 | De Novo | Apparatus, Nitric Oxide Delivery | 2000-01-11 |
Recalls
13 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2018-10-05.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Ohmeda Medical's product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Ohmeda Medical have?
Ohmeda Medical has 119 FDA 510(k) clearances (first 1984, latest 2013), plus 1 De Novo decision, across 41 product codes in 5 review panels.
How long does FDA take to clear Ohmeda Medical's 510(k)s?
The median time from FDA receipt to decision across Ohmeda Medical's cleared 510(k)s is 79 days.
What devices does Ohmeda Medical make?
Its most frequent FDA product codes are BSZ (Gas-Machine, Anesthesia, 17); FMZ (Incubator, Neonatal, 15); CBK (Ventilator, Continuous, Facility Use, 10).
Has Ohmeda Medical had device recalls?
openFDA lists 13 product recalls in 3 recall events by a recalling firm whose name matches Ohmeda Medical; the most recent began 2018-10-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 119 Ohmeda Medical clearances with predicates and recalls
- Run predicate analysis for product code BSZ, Ohmeda Medical'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.