Cleared Traditional

SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. (K885235) - FDA 510(k) Clearance

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

K885235 · Spectramed, Inc. · Cardiovascular device
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Jan 1989
Decision
36d
Days
Class 2
Risk

K885235 is an FDA 510(k) clearance for the SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Spectramed, Inc. (Oxnard, US). The FDA issued a Cleared decision on January 25, 1989 after a review of 36 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K885235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1988
Decision Date January 25, 1989
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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 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 76
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K885235.
Endophys Blood Pressure Monitor model BPM-30
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MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
CARDIAC OUTPUT MODULE-78231C
K772234 · Hewlett-Packard Co. · Jan 1978
CARDIAC OUTPUT COMPUTER MODEL 701
K771977 · Instrumentation Laboratory CO · Jan 1978