Cleared Traditional

K981973 - SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

K981973 is an FDA 510(k) clearance for SAFE-T-FILL CAPILLARY BLOOD COLLECTION ..., manufactured by Ram Scientific. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981973 · Ram Scientific · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
90d
Days
Class 2
Risk

K981973 is an FDA 510(k) clearance for the SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Ram Scientific (Washington, US). The FDA issued a Cleared decision on September 3, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ram Scientific devices

FDA 510(k) Submission Details - K981973

510(k) Number K981973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1998
Decision Date September 03, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, 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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 143
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K981973.
GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE
K982998 · Greiner Meditech, Inc. · Oct 1998
GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE
K982999 · Greiner Meditech, Inc. · Oct 1998
VACUTAINER BRAND BLOOD COLLECTION SYRINGE
K982922 · Becton Dickinson Vacutainer Systems · Sep 1998
VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE
K981013 · Becton Dickinson Vacutainer Systems · Jun 1998
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
K981035 · Sims Portex, Inc. · Apr 1998
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET
K980414 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1998