Cleared Traditional

K901998 - DIGITAL MANOMETER (DM 50)

K901998 is an FDA 510(k) clearance for DIGITAL MANOMETER (DM 50), manufactured by Medical Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code BXR cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K901998 · Medical Support Products, Inc. · Anesthesiology device
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Jul 1990
Decision
84d
Days
Class 2
Risk

K901998 is an FDA 510(k) clearance for the DIGITAL MANOMETER (DM 50). Classified as Meter, Airway Pressure (inspiratory Force) (product code BXR), Class II - Special Controls.

Submitted by Medical Support Products, Inc. (Lancaster, US). The FDA issued a Cleared decision on July 25, 1990 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1780 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K901998

510(k) Number K901998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1990
Decision Date July 25, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BXR Device Classification - Class 2, Special Controls

Product Code BXR Meter, Airway Pressure (inspiratory Force)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BXR Meter, Airway Pressure (inspiratory Force)

Devices cleared under the same product code (BXR) and FDA review panel - the closest regulatory comparables to K901998.
NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
K081693 · Instrumentation Industries, Inc. · Sep 2008
MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
K032593 · Mercury Medical · Feb 2004
INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING
K873498 · Dhd Medical Products Div. Diemolding Corp. · Mar 1988
K901998 · DIGITAL MANOMETER (DM 50)
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