510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901998Substantially Equivalent

Digital Manometer (Dm 50)

Medical Support Products, Inc., Lancaster PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901998 is the FDA 510(k) clearance record for DIGITAL MANOMETER (DM 50), a class II device, cleared for Medical Support Products, Inc. on under FDA product code BXR (Meter, Airway Pressure (Inspiratory Force)). FDA records list one 510(k) clearance for Medical Support Products, Inc. As of , FDA records show no recalls naming K901998.

Clearance record

Decision date
Received
(84 days to decision)
Product code
BXR Meter, Airway Pressure (Inspiratory Force)
Regulation
21 CFR 868.1780
Device class
Class II
Review panel
Anesthesiology
Applicant
Medical Support Products, Inc. 3401 Charlestown Rd., Lancaster PA
Third party review
No

Clearances, product code BXR

Trailing 12 months

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

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