Cleared Traditional

K821894 - DISPOSABLE TRANSDUCER DOMES & KITS

K821894 is an FDA 510(k) clearance for DISPOSABLE TRANSDUCER DOMES & KITS, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K821894 · American Pharmaseal Div. Ahsc · Cardiovascular device
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Jul 1982
Decision
22d
Days
Class 2
Risk

K821894 is an FDA 510(k) clearance for the DISPOSABLE TRANSDUCER DOMES & KITS. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K821894

510(k) Number K821894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date July 20, 1982
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 87
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K821894.
DISPOSABLE PRESSURE TRANSDUCER
K830210 · American Pharmaseal Div. Ahsc · Apr 1983
USCI ELECTRONIC MANOMETER
K830093 · C.R. Bard, Inc. · Jan 1983
DISPOSABLE TRANSDUCER & ACCESSORIES
K822507 · Gould, Inc. · Sep 1982
DISPOSABLE BLOOD PRESSURE TRANSDUCER
K821416 · Bentley Laboratories, Inc. · Jul 1982
VIRAGARD/VIRASHIELD
K820459 · Tri-Med, Inc. · Jun 1982
PRESSURE TUBING-ADULT & PEDIATRIC
K821450 · Gould, Inc. · May 1982