510(k) Report

FDA applicant

Renu Medical, Inc.

Everett, WA9 decisions2003–20210 recalls

FDA records 9 decisions for Renu Medical, Inc. (Everett, WA) from 2003 to 2021: 9 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and NLF (Oximeter, Reprocessed). Its devices cite 16 predicates, 6 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 Renu Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 22009: 12010: 12011: 12012: 12021: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Renu Medical, 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, Compressible5decisions
  • NLFOximeter, Reprocessed4decisions

Whose devices does it build on?

Its devices cite 16 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 6 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.

  • K031559Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 20032cite it
  • K051227Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 20062cite it
  • K072194Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25Renu Medical, Inc. · 20072cite it
  • K063661Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20Renu Medical, Inc. · 20071cites it
  • K081927Renu Medical Oximetry Sensor, Adult, Ped, Inf,NeoRenu Medical, Inc. · 20091cites it

What has FDA decided for it lately?

  • K203847Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021
  • K121145Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical Reprocessed Aircast Venaflow…Renu Medical, Inc. · 2012
  • K111773Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and NeonateRenu Medical, Inc. · 2011
  • K093658Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot GarmentsRenu Medical, Inc. · 2010
  • K081927Renu Medical Oximetry Sensor, Adult, Ped, Inf,NeoRenu Medical, Inc. · 2009
  • K072194Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25Renu Medical, Inc. · 2007
  • K063661Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20Renu Medical, Inc. · 2007
  • K051227Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006

All 9 as Renu Medical, Inc. →