Cleared Traditional

K811538 - MODELS TA 1017 & 1017T GRITIFLO DISPOS

K811538 is the FDA 510(k) clearance for MODELS TA 1017 & 1017T GRITIFLO DISPOS by Gould, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K811538 · Gould, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
11d
Days
Class 2
Risk

K811538 is an FDA 510(k) clearance for the MODELS TA 1017 & 1017T GRITIFLO DISPOS. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Gould, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 11 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 Gould, Inc. devices

Submission Details

510(k) Number K811538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1981
Decision Date June 12, 1981
Days to Decision 11 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
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K811538.
TELECARE ISOTEC PRESSURE TRANSDUCER DOME
K812883 · Narco Scientific · Nov 1981
NARCO TELECARE PRESSURE TRANSDUCER DOME
K812884 · Narco Scientific · Nov 1981
PHYSIOLOGICAL PRESSURE TRANSDUCER
K812758 · Electromedics, Inc. · Oct 1981
COBE DISPOSABLE PRESSURE TRANSDUCER
K810637 · Cobe Laboratories, Inc. · Apr 1981
CATHDAMP
K810661 · Medline Industries, Inc. · Mar 1981
DISPOSABLE DIAPHRAGM DOME
K810009 · Medex, Inc. · Feb 1981