510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791705Substantially Equivalent

4200 Pneumatic Mouth Shutter

Hans Rudolph, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791705 is the FDA 510(k) clearance record for 4200 PNEUMATIC MOUTH SHUTTER, a class II device, cleared for Hans Rudolph, Inc. on under FDA product code CCM (Plethysmograph, Pressure). FDA records list 11 510(k) clearances for Hans Rudolph, Inc., from to . As of , FDA records show no recalls naming K791705.

Clearance record

Decision date
Received
(37 days to decision)
Product code
CCM Plethysmograph, Pressure
Regulation
21 CFR 868.1750
Device class
Class II
Review panel
Anesthesiology
Applicant
Hans Rudolph, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CCM

Trailing 12 months

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

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