510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962848Substantially Equivalent

Hans Rudolph Nasal CPAP Mask

Hans Rudolph, Inc., Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962848 is the FDA 510(k) clearance record for HANS RUDOLPH NASAL CPAP MASK, a class I device, cleared for Hans Rudolph, Inc. on under FDA product code BYG (Mask, Oxygen). FDA records list 11 510(k) clearances for Hans Rudolph, Inc., from to . As of , FDA records show no recalls naming K962848.

Clearance record

Decision date
Received
(86 days to decision)
Product code
BYG Mask, Oxygen
Regulation
21 CFR 868.5580
Device class
Class I
Review panel
Anesthesiology
Applicant
Hans Rudolph, Inc. 7200 Wyandotte, Kansas City MO
510(k) summary
Statement
Third party review
No

Clearances, product code BYG

Trailing 12 months

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

FDA records show no clearances under product code BYG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYG, 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