Hygia Health Services, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Hygia Health Services, Inc.” (first 2002, latest 2010), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 224 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 9 | 9 |
| NLF | Oximeter, Reprocessed | 3 | 3 |
| NMD | Oximeter, Tissue Saturation, Reprocessed | 1 | 1 |
| NPP | Reprocessed Blood Pressure Cuff | 1 | 1 |
Review panels
- Cardiovascular (11)
- Anesthesiology (3)
Most recent Hygia Health Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100523 | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA | NMD | 2010-05-04 | 69 |
| K090074 | HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS | JOW | 2009-04-22 | 100 |
| K080424 | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 | NLF | 2008-05-28 | 103 |
| K053575 | HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS | JOW | 2006-02-15 | 55 |
| K041867 | HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N | NLF | 2004-09-10 | 63 |
| K032821 | HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF | NPP | 2003-12-05 | 91 |
| K012715 | HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II | NLF | 2003-08-01 | 717 |
| K021509 | HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 | JOW | 2002-12-24 | 229 |
| K012657 | HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP | JOW | 2002-04-12 | 242 |
| K012654 | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 | JOW | 2002-04-12 | 242 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hygia Health Services, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hygia Health Services, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Hygia Health Services, Inc.” (first 2002, latest 2010), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hygia Health Services, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hygia Health Services, Inc. is 224 days.
Which FDA product codes appear under Hygia Health Services, Inc.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 9); NLF (Oximeter, Reprocessed, 3); NMD (Oximeter, Tissue Saturation, Reprocessed, 1).
Next steps
- See all 14 Hygia Health Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Hygia Health Services, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.