510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012770Substantially Equivalent

Infinity Micro2+

Siemens Medical Solutions USA, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012770 is the FDA 510(k) clearance record for INFINITY MICRO2+, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code DQA (Oximeter). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K012770.

Clearance record

Decision date
Received
(340 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Siemens Medical Solutions USA, Inc. 16 Electronics Ave., Danvers MA
510(k) summary
Summary
Third party review
No

Clearances, product code DQA

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