Cleared Traditional

K822097 - D645-BACTERIOLOGICAL GAS LINE FILTER

K822097 is an FDA 510(k) clearance for D645-BACTERIOLOGICAL GAS LINE FILTER, manufactured by Electromedics, Inc.. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K822097 · Electromedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
14d
Days
Class 1
Risk

K822097 is an FDA 510(k) clearance for the D645-BACTERIOLOGICAL GAS LINE FILTER. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Electromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982 after a review of 14 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 Electromedics, Inc. devices

FDA 510(k) Submission Details - K822097

510(k) Number K822097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1982
Decision Date July 30, 1982
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

KRI Device Classification - Class 1, General Controls

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 30
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K822097.
SHILEY GAS FILTER
K832704 · Shiley, Inc. · Sep 1983
GASLINE FILTER #GF-10
K832411 · American Bentley · Sep 1983
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA-
K830167 · American Bentley · Mar 1983
TMO INTEGRATED CIRCUIT SYSTEM
K820406 · Travenol Laboratories, S.A. · Mar 1982
CARDIOPLEGIA COOLING & ADMIN. SETS
K811368 · Bentley Laboratories, Inc. · Jun 1981
CARDIOPULMONARY BYPASS ACCESSORY EQUIP.
K811348 · Bentley Laboratories, Inc. · May 1981