510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083892Substantially Equivalent

Fore-Sight, Model Mc-2000 Series (Mc-2000, Mc-2010, Mc2020, Mc2030)

Cas Medical Systems, Inc., Branford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083892 is the FDA 510(k) clearance record for FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030), a class II device, cleared for Cas Medical Systems, Inc. on under FDA product code DQA (Oximeter). FDA records list 32 510(k) clearances for Cas Medical Systems, Inc., from to . As of , FDA records show no recalls naming K083892.

Clearance record

Decision date
Received
(80 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Cas Medical Systems, Inc. 44 E. Industrial Rd., Branford CT
510(k) summary
Summary PDF
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