Cleared Traditional

K830639 - HI FLEX D-700 MODULAR BUBBLE OXYGENA-

K830639 is an FDA 510(k) clearance for HI FLEX D-700 MODULAR BUBBLE OXYGENA-, manufactured by Electromedics, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K830639 · Electromedics, Inc. · Cardiovascular device
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May 1983
Decision
85d
Days
Class 2
Risk

K830639 is an FDA 510(k) clearance for the HI FLEX D-700 MODULAR BUBBLE OXYGENA-. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Electromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 Electromedics, Inc. devices

FDA 510(k) Submission Details - K830639

510(k) Number K830639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1983
Decision Date May 25, 1983
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 221
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K830639.
BLOOD OXYGENATOR 5070
K831894 · Shiley, Inc. · Oct 1983
BLOOD OXYGENATOR 50 70/S
K831895 · Shiley, Inc. · Oct 1983
WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
K831705 · C.R. Bard, Inc. · Jul 1983
WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-
K831122 · C.R. Bard, Inc. · May 1983
DOSIMETRIC RELEASE OF RADIATION DEV
K830327 · American Bentley · Mar 1983
BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.
K823273 · Bentley Laboratories, Inc. · Jan 1983