510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032403Substantially Equivalent

Smartmonitor 2 Professional Series (Ps)

Respironics, Inc., Murrysville PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032403 is the FDA 510(k) clearance record for SMARTMONITOR 2 PROFESSIONAL SERIES (PS), a class II device, cleared for Respironics, Inc. on under FDA product code NPF (Monitor, Apnea, Home Use). FDA's definition for product code NPF reads: "Same as the identification for product code FLS, just add home use". FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show one recall naming K032403.

Clearance record

Decision date
Received
(84 days to decision)
Product code
NPF Monitor, Apnea, Home Use
Regulation
21 CFR 868.2377
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPF

Trailing 12 months

FDA records hold no clearances under product code NPF in the trailing twelve months.

FDA records show no clearances under product code NPF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260