Olympic Medical Corp.: FDA clearances and approvals
Olympic Medical Corp. has 37 FDA 510(k) clearances (first 1978, latest 2008), across 21 product codes in 8 review panels. Median 510(k) review time: 80 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
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 |
|---|---|---|---|
| FRW | Scale, Patient | 7 | 7 |
| LBI | Unit, Neonatal Phototherapy | 6 | 6 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| FTY | Tape, Measuring, Rulers And Calipers | 2 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 2 | 2 |
| LDS | Device, Pasteurization, Hot Water | 2 | 2 |
| OMA | Amplitude-Integrated Electroencephalograph | 2 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CBH | Device, Fixation, Tracheal Tube | 1 | 1 |
| FEW | Catheter, Malecot | 1 | 1 |
Plus 11 more product codes.
Review panels
- General Hospital (23)
- Neurology (3)
- Anesthesiology (2)
- Cardiovascular (2)
- Physical Medicine (2)
- General and Plastic Surgery (2)
- Clinical Chemistry (1)
- Gastroenterology and Urology (1)
Most recent Olympic Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 | MEC | 2008-06-20 | 64 |
| K031149 | OLYMPIC CFM 6000 | OMA | 2003-05-14 | 34 |
| K020335 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 | OMC | 2002-06-18 | 137 |
| K001056 | OLYMPIC WARM-UP | ILY | 2000-09-29 | 179 |
| K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | OMA | 1999-03-23 | 189 |
| K971601 | OLYMPIC BILI-BASSINET | LBI | 1997-09-24 | 146 |
| K972193 | OLYMPIX MINI-PASTEURMATIC (58210) | LDS | 1997-09-05 | 87 |
| K971117 | WARMETTE | LHC | 1997-08-22 | 148 |
| K955357 | OLYMPIC SMART SCALE MODEL 50/50RA | FRW | 1996-01-30 | 99 |
| K954434 | OLYMPIC INFANT THERMOMETER | FLL | 1995-12-20 | 86 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Olympic Medical Corp..
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.
Device clinical trials
Olympic Medical Corp. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00383305: CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy (Completed, started 1999-07)
Frequently asked questions
How many FDA 510(k) clearances does Olympic Medical Corp. have?
Olympic Medical Corp. has 37 FDA 510(k) clearances (first 1978, latest 2008), across 21 product codes in 8 review panels.
How long does FDA take to clear Olympic Medical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Olympic Medical Corp.'s cleared 510(k)s is 80 days.
What devices does Olympic Medical Corp. make?
Its most frequent FDA product codes are FRW (Scale, Patient, 7); LBI (Unit, Neonatal Phototherapy, 6); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2).
Has Olympic Medical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Olympic Medical Corp. Related entities may recall under other names.
Next steps
- See all 37 Olympic Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FRW, Olympic Medical Corp.'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.