Cleared Traditional

K841296 - TUBE TENDER

K841296 is the FDA 510(k) clearance for TUBE TENDER by The Anspach Effort, Inc.. It is a Class 1 Cardiovascular device (product code KRI) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K841296 · The Anspach Effort, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
73d
Days
Class 1
Risk

K841296 is an FDA 510(k) clearance for the TUBE TENDER. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4200 - 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K841296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1984
Decision Date June 11, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KRI Accessory Equipment, Cardiopulmonary Bypass
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4200
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 - KRI Accessory Equipment, Cardiopulmonary Bypass

All 23
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K841296.
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
K854113 · American Bentley · Jan 1986
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
K852455 · Gambro, Inc. · Sep 1985
COBE GAS FILTER
K851289 · Cobe Laboratories, Inc. · Jun 1985
HOLDER FOR BOS-10, 10S 5S
K841812 · American Bentley · Jun 1984
HOLDER FOR MODELS AF-10,1025,1040,5
K841032 · American Bentley · Apr 1984
SHILEY GAS FILTER
K832704 · Shiley, Inc. · Sep 1983