Cleared Traditional

K780798 - GOULD-STATHAM SP1405 PRESSURE MONITOR

K780798 is an FDA 510(k) clearance for GOULD-STATHAM SP1405 PRESSURE MONITOR, manufactured by Gould, Inc.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K780798 · Gould, Inc. · Cardiovascular device
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Jun 1978
Decision
29d
Days
Class 2
Risk

K780798 is an FDA 510(k) clearance for the GOULD-STATHAM SP1405 PRESSURE MONITOR. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Gould, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1978 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Gould, Inc. devices

FDA 510(k) Submission Details - K780798

510(k) Number K780798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1978
Decision Date June 13, 1978
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 48
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K780798.
MONITOR, PRESSURVEIL
K790135 · Concept, Inc. · Feb 1979
DINAMAP MODEL 846
K781053 · Applied Medical Research · Sep 1978
DINAMAP MODEL 848
K781064 · Applied Medical Research · Sep 1978
MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP
K772334 · Telectronics, Inc. · Feb 1978
MINIMAP MODEL 810
K771981 · Applied Medical Research · Jan 1978
CARDIAC OUTPUT MODULE-78231C
K772234 · Hewlett-Packard Co. · Jan 1978