510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001085Substantially Equivalent

Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500

Nonin Medical, Inc, Plymouth MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001085 is the FDA 510(k) clearance record for MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500, a class II device, cleared for Nonin Medical, Inc. on under FDA product code DQA (Oximeter). FDA records list 50 510(k) clearances for Nonin Medical, Inc., from to . As of , FDA records show no recalls naming K001085.

Clearance record

Decision date
Received
(27 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Nonin Medical, Inc. 2605 Fernbrook Ln., N., Plymouth MN
510(k) summary
Summary
Third party review
No

Clearances, product code DQA

Trailing 12 months
12 clearances under product code DQA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
November 20252
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260