Cleared Traditional

K830910 - MANOMETER SET C.V.P. #S 298/299

K830910 is an FDA 510(k) clearance for MANOMETER SET C.V.P. #S 298/299, manufactured by Exco, Inc.. The device is a Class 2 Cardiovascular device with product code KRK cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K830910 · Exco, Inc. · Cardiovascular device
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Apr 1983
Decision
15d
Days
Class 2
Risk

K830910 is an FDA 510(k) clearance for the MANOMETER SET C.V.P. #S 298/299. Classified as Manometer, Blood-pressure, Venous (product code KRK), Class II - Special Controls.

Submitted by Exco, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1140 - the FDA cardiovascular device oversight 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.

View all Exco, Inc. devices

FDA 510(k) Submission Details - K830910

510(k) Number K830910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date April 05, 1983
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRK Device Classification - Class 2, Special Controls

Product Code KRK Manometer, Blood-pressure, Venous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1140
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRK Manometer, Blood-pressure, Venous

Devices cleared under the same product code (KRK) and FDA review panel - the closest regulatory comparables to K830910.
UST-5268P-5 TRANSDUCER
K950607 · Aloka Co., Ltd. · Sep 1995
CENTRAL VENOUS PRESSURE MANOMETER
K904674 · Medex, Inc. · Dec 1990
SCHNEIDER-SHILEY PRESSURE MANOMETER
K861605 · Shiley, Inc. · May 1986
MEDIFIX
K813498 · Burron Medical Products, Inc. · Jan 1982
MEDIFIX GRADUATED SCALE
K813195 · Burron Medical Products, Inc. · Dec 1981