510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971273Substantially Equivalent

Index 2E, Index 2F, Index 2Ef, Cardiosat 100E, Cardiosat 100F, Cardiosat 100Ef

Bio-Tek Instruments, Inc., Winooski VT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971273 is the FDA 510(k) clearance record for INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF, a class II device, cleared for Bio-Tek Instruments, Inc. on under FDA product code DQA (Oximeter). FDA records list 37 510(k) clearances for Bio-Tek Instruments, Inc., from to . As of , FDA records show no recalls naming K971273.

Clearance record

Decision date
Received
(184 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Bio-Tek Instruments, Inc. Highland Park, Winooski VT
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