Cleared Traditional

K862344 - GOULD XCALIBER

K862344 is the FDA 510(k) clearance for GOULD XCALIBER by Bio-Tek Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K862344 · Bio-Tek Instruments, Inc. · Cardiovascular device
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Aug 1986
Decision
47d
Days
Class 2
Risk

K862344 is an FDA 510(k) clearance for the GOULD XCALIBER. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Bio-Tek Instruments, Inc. (Winooski, US). The FDA issued a Cleared decision on August 6, 1986 after a review of 47 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 Bio-Tek Instruments, Inc. devices

Submission Details

510(k) Number K862344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1986
Decision Date August 06, 1986
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 85
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K862344.
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
K872596 · American Edwards Laboratories · Sep 1987
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER
K870301 · Medex, Inc. · May 1987
SHELF LIFE CHANGE OF STERILE DEVICES
K864090 · Utah Medical Products, Inc. · Mar 1987
DISPOSABLE FLUSH DEVICE
K860681 · Hewlett-Packard Co. · Jun 1986
MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
K855145 · Gould, Inc. · Feb 1986
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
K851486 · Gould, Inc. · Oct 1985