Cleared Traditional

CAPIOX SX HARDSHELL RESERVOIR (K980935) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980935 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
63d
Days
Class 2
Risk

K980935 is an FDA 510(k) clearance for the CAPIOX SX HARDSHELL RESERVOIR. 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 May 14, 1998 after a review of 63 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

Submission Details

510(k) Number K980935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1998
Decision Date May 14, 1998
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K980935.
CAPIOX SX10 HARDSHELL RESEVOIR
K991973 · Terumo Medical Corp. · Sep 1999
CAPIOX SX HARDSHELL RESEVOIR
K982223 · Terumo Medical Corp. · Sep 1998
BARD QUANTUM SVR MODEL NUMBER H-6440VR
K981628 · C.R. Bard, Inc. · Aug 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
K974155 · Baxter Healthcare Corp · Jan 1998
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · Medtronic Vascular · Nov 1996
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K933713 · Baxter Healthcare Corp · Mar 1994