Cleared Traditional

K930154 - EL2-SERIES BLOOD COLLECTION REERVOIR

K930154 is an FDA 510(k) clearance for EL2-SERIES BLOOD COLLECTION REERVOIR, manufactured by Electromedics, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K930154 · Electromedics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1993
Decision
169d
Days
Class 2
Risk

K930154 is an FDA 510(k) clearance for the EL2-SERIES BLOOD COLLECTION REERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on July 1, 1993 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Electromedics, Inc. devices

FDA 510(k) Submission Details - K930154

510(k) Number K930154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1993
Decision Date July 01, 1993
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
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 143
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K930154.
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K933713 · Baxter Healthcare Corp · Mar 1994
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286 · Gish Biomedical, Inc. · Feb 1994
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299 · C.R. Bard, Inc. · Jun 1993
CARDIOTOMY RESERVOIR W/20 MICRON FILITER
K920178 · Lifestream Int'L, Inc. · May 1993
PLEUR-EVAC CARDIOTOMY RESERVOIR
K925046 · Deknatel, Inc. · Apr 1993