Cleared Traditional

K771489 - RTERIAL BLOOD SAMPLING KIT

K771489 is the FDA 510(k) clearance for RTERIAL BLOOD SAMPLING KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Hematology device (product code GJE) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K771489 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1977
Decision
17d
Days
Class 2
Risk

K771489 is an FDA 510(k) clearance for the RTERIAL BLOOD SAMPLING KIT. Classified as Tray, Blood Collection (product code GJE), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 22, 1977 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1675 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K771489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1977
Decision Date August 22, 1977
Days to Decision 17 days
Submission Type Traditional
Review Panel Hematology (HE)
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: 113d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJE Tray, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Hematology devices follow this clearance model.

Regulatory Peers - GJE Tray, Blood Collection

Devices cleared under the same product code (GJE) and FDA review panel - the closest regulatory comparables to K771489.
CUSTOMED BLOOD EXTRACTION KIT
K962596 · Customed, Inc. · Sep 1996
AUTO ISO-FILTER COLLECTION TUBE CAP
K780303 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978
ICROTAINEO BRAND TUBE
K771370 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1977
SODIUM CITRATE
K761177 · Bio/Data Corp. · Jan 1977
TRAY, BLOOD SAMPLING (PULSATOR II)
K760086 · Concord Laboratories, Inc. · Jul 1976