510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960251Substantially Equivalent

Comsat Adult,pediatric,infant,neonatal Disposable Sensor and Comsat Reusable Finger Sensor

Aristo Medical Products, Inc., Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960251 is the FDA 510(k) clearance record for COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR, a class II device, cleared for Aristo Medical Products, Inc. on under FDA product code DQA (Oximeter). FDA records list 4 510(k) clearances for Aristo Medical Products, Inc., from to . As of , FDA records show no recalls naming K960251.

Clearance record

Decision date
Received
(68 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Aristo Medical Products, Inc. 407 Pilot Ct., #400-A, Waukesha WI
510(k) summary
Statement
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