Cleared Traditional

K881262 - CARAWAY TUBES

K881262 is the FDA 510(k) clearance for CARAWAY TUBES by Helps Products, Inc.. It is a Class 1 Hematology device (product code GIO) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K881262 · Helps Products, Inc. · Hematology device
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May 1988
Decision
43d
Days
Class 1
Risk

K881262 is an FDA 510(k) clearance for the CARAWAY TUBES, HEPARIN AND PLAIN. Classified as Tube, Collection, Capillary Blood (product code GIO), Class I - General Controls.

Submitted by Helps Products, Inc. (Orlando, US). The FDA issued a Cleared decision on May 6, 1988 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6150 - the FDA hematology device 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 Helps Products, Inc. devices

Submission Details

510(k) Number K881262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1988
Decision Date May 06, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 113d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIO Tube, Collection, Capillary Blood
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GIO Tube, Collection, Capillary Blood

All 12
Devices cleared under the same product code (GIO) and FDA review panel - the closest regulatory comparables to K881262.
MONOJECT SAMPLETTE SEPARATOR TUBE
K941291 · Sherwood Medical Co. · Oct 1994
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
K875061 · Sherwood Medical Co. · Jan 1988
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
K873647 · Ventrex Laboratories, Inc. · Oct 1987
CORNING BLOOD COLLECTION CAPILLARY TUBES
K850806 · Corning Medical & Scientific · Mar 1985
MICRO HEMATOCRIT CAPILLARY TUBES
K843892 · Abco Dealers, Inc. · Nov 1984
MONOJET SAMPLETTE ADAPTERS
K832578 · Sherwood Medical Co. · Aug 1983