Cleared Traditional

PRESSURE INFUSION CUFF (K781556) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K781556 · Abbott Laboratories · Cardiovascular device
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Oct 1978
Decision
36d
Days
Class 2
Risk

K781556 is an FDA 510(k) clearance for the PRESSURE INFUSION CUFF. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K781556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1978
Decision Date October 17, 1978
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 280
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K781556.
CONPHAR CHECKMATE SPHYGMOMANOMETER
K801187 · Conphar, Inc. · Jun 1980
HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC
K791054 · C.R. Bard, Inc. · Jul 1979
QUICK-CHECK
K790277 · United States Surgical, A Division of Tyco Healthc · Mar 1979
TREND II ANEROID
K780598 · Abco Dealers, Inc. · Jun 1978
ELHCTRONIC SPHYGMOMANOMETER
K771393 · C.R. Bard, Inc. · Nov 1977
ELECTRONIC STETHESCOPE
K771394 · C.R. Bard, Inc. · Nov 1977