510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K100343Substantially Equivalent

Pap-Cap

Pur-Sleep, Inc., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100343 is the FDA 510(k) clearance record for PAP-CAP, a class II device, cleared for Pur-Sleep, Inc. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list one 510(k) clearance for Pur-Sleep, Inc. As of , FDA records show no recalls naming K100343.

Clearance record

Decision date
Received
(77 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Pur-Sleep, Inc. 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260