510(k) Report

FDA applicant

Hygia Health Services, Inc.

Birmingham, AL14 decisions2002–20100 recalls

FDA records 14 decisions for Hygia Health Services, Inc. (Birmingham, AL) from 2002 to 2010: 14 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and NLF (Oximeter, Reprocessed). Its devices cite 38 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Hygia Health Services, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12009: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hygia Health Services, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hygia Health Services, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JOWSleeve, Limb, Compressible9decisions
  • NLFOximeter, Reprocessed3decisions
  • NMDOximeter, Tissue Saturation, Reprocessed1decision
  • NPPReprocessed Blood Pressure Cuff1decision

Whose devices does it build on?

Its devices cite 38 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012417Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480Hygia Health Services, Inc. · 20024cite it
  • K012654Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20, DVT 30, DVT 40Hygia Health Services, Inc. · 20024cite it
  • K012650Hygia Health Services Reprocessed Nutech Foot WrapHygia Health Services, Inc. · 20023cite it
  • K012651Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200Hygia Health Services, Inc. · 20023cite it
  • K021509Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089Hygia Health Services, Inc. · 20023cite it
  • K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc. · 20042cite it

What has FDA decided for it lately?

  • K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM…Hygia Health Services, Inc. · 2010
  • K090074Hygia Health Services Reprocessed Compression Sleeves / Foot CuffsHygia Health Services, Inc. · 2009
  • K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and HHS-1861Hygia Health Services, Inc. · 2008
  • K053575Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot CuffsHygia Health Services, Inc. · 2006
  • K041867Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-NHygia Health Services, Inc. · 2004
  • K032821Hygia Health Services Reprocessed Blood Pressure CuffHygia Health Services, Inc. · 2003
  • K012715Hygia Health Services Reprocessed Nellcot D-25 Oxisensor IIHygia Health Services, Inc. · 2003
  • K021509Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089Hygia Health Services, Inc. · 2002

All 14 as Hygia Health Services, Inc. →