Cleared Traditional

K991973 - CAPIOX SX10 HARDSHELL RESEVOIR

K991973 is an FDA 510(k) clearance for CAPIOX SX10 HARDSHELL RESEVOIR, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K991973 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
84d
Days
Class 2
Risk

K991973 is an FDA 510(k) clearance for the CAPIOX SX10 HARDSHELL RESEVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K991973

510(k) Number K991973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1999
Decision Date September 03, 1999
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 135
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K991973.
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · Terumo Cardiovascular Systems Corp. · Aug 2000
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K994389 · Cobe Cardiovascular, Inc. · Mar 2000
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
K993001 · Cobe Cardiovascular, Inc. · Dec 1999
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K990239 · Cobe Cardiovascular, Inc. · May 1999
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K984456 · Cobe Cardiovascular, Inc. · Jan 1999
CAPIOX SX HARDSHELL RESEVOIR
K982223 · Terumo Medical Corp. · Sep 1998