Cleared Traditional

K884623 - SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE

K884623 is an FDA 510(k) clearance for SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE, manufactured by Safe-Tec Clinical Products, Inc.. The device is a Class 1 Hematology device with product code GIO cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K884623 · Safe-Tec Clinical Products, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
27d
Days
Class 1
Risk

K884623 is an FDA 510(k) clearance for the SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE. Classified as Tube, Collection, Capillary Blood (product code GIO), Class I - General Controls.

Submitted by Safe-Tec Clinical Products, Inc. (Ivyland, US). The FDA issued a Cleared decision on December 1, 1988 after a review of 27 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.

FDA 510(k) Submission Details - K884623

510(k) Number K884623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1988
Decision Date December 01, 1988
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

GIO Device Classification - Class 1, General Controls

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 21
Devices cleared under the same product code (GIO) and FDA review panel - the closest regulatory comparables to K884623.
TRU-TRAX
K894851 · Humagen, Inc. · Sep 1989
HEMA(PRO)TEC(TION)
K885324 · Medical Products Search, Inc. · Feb 1989
CAPILLARY TUBE, BLOOD COLLECTION
K885138 · Coeur Laboratories, Inc. · Feb 1989
NATELSON TUBES, HEPARIN AND PLAIN
K881187 · Helps Products, Inc. · May 1988
CARAWAY TUBES, HEPARIN AND PLAIN
K881262 · Helps Products, Inc. · May 1988
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
K875061 · Sherwood Medical Co. · Jan 1988
K884623 · SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
Download PDF Safe-Tec Clinical Pro…