510(k) Report

FDA applicant

Nonin Medical, Inc.

Plymouth, MN50 decisions1986–20246 recalls

FDA records 50 decisions for Nonin Medical, Inc. (Plymouth, MN) from 1986 to 2024: 50 510(k) clearances. Most are in product codes DQA (Oximeter) and MUD (Oximeter, Tissue Saturation). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 202 for FDA’s reviews in the same codes and years. Its devices cite 71 predicates, 53 of them its own earlier devices. 6 recalls are 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 Nonin Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 32008: 22009: 32010: 42012: 22013: 12014: 22015: 12016: 22018: 12019: 22020: 12024: 1
2007high 4 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007: 22009: 12014: 12016: 1
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Nonin 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?

  • DQAOximeter42decisions
  • MUDOximeter, Tissue Saturation5decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • OLKPulse Oximeter For Over-The-Counter Use1decision
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 231 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 202 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 71 predicates; 53 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 105 times; 53 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.

  • K050056Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 20058cite it
  • K002690Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Nonin Medical, Inc. · 20007cite it
  • K102715Regional OximeterNonin Medical, Inc. · 20106cite it
  • K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 20045cite it
  • K080255Nonin Medical, Inc., Model 7500 Digital Pulse OximeterNonin Medical, Inc. · 20085cite it
  • K051107Onyx II Finger Pulse Oximeter, Model 9550Nonin Medical, Inc. · 20054cite it

What has FDA decided for it lately?

  • K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc. · 2024
  • K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020
  • K191403Pulse OximeterNonin Medical, Inc. · 2019
  • K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient InterfaceNonin Medical, Inc. · 2019
  • K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorNonin Medical, Inc. · 2018
  • K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. · 2016
  • K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP…Nonin Medical, Inc. · 2016
  • K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional…Nonin Medical, Inc. · 2015

All 50 as Nonin Medical, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K8932218500M Handheld Pulse OximeterSep 29, 2016Class II
  • K132402SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model…Nov 25, 2014Class II
  • K090807Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional…Oct 23, 2009
  • K002690Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep…Oct 15, 2007
  • K002690Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USAOct 11, 2007
  • K041156Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.Jul 29, 2005