510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K942227Substantially Equivalent

Nicas 2001 Noninvasive Cardio-Respiratory System

C.L. Mcintosh & Assoc., Inc., Lexington KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942227 is the FDA 510(k) clearance record for NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM, a class II device, cleared for C.L. Mcintosh & Assoc., Inc. on under FDA product code DSB (Plethysmograph, Impedance). FDA records list 4 510(k) clearances for C.L. Mcintosh & Assoc., Inc., from to . As of , FDA records show no recalls naming K942227.

Clearance record

Decision date
Received
(784 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
C.L. Mcintosh & Assoc., Inc. 1384 Copperfield Ct., Lexington KY
510(k) summary
Summary
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260