Cleared Traditional

K842369 - ELECATH INFANT ARTERIAL & VENOUS CANNU

K842369 is an FDA 510(k) clearance for ELECATH INFANT ARTERIAL & VENOUS CANNU, manufactured by Electro-Catheter Corp.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K842369 · Electro-Catheter Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
73d
Days
Class 2
Risk

K842369 is an FDA 510(k) clearance for the ELECATH INFANT ARTERIAL & VENOUS CANNU. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1984 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - the FDA anesthesiology and respiratory device 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 Electro-Catheter Corp. devices

FDA 510(k) Submission Details - K842369

510(k) Number K842369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date August 27, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 140d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BWF Spirometer, Therapeutic (incentive)

All 45
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K842369.
AMBU RMT VALVE
K873579 · Ambu, Inc. · Dec 1987
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334 · American Pharmaseal Div. Ahsc · Aug 1985
VITAPEP
K844963 · Vitalograph , Ltd. · Jun 1985
VOFLEX
K840239 · Dhd Medical Products Div. Diemolding Corp. · Mar 1984
INSPIRATORY/EXPIRATORY MUSCLE EXERCIS
K840418 · Inspiron Corp. · Feb 1984
VOLUREX II
K833337 · Dhd Medical Products Div. Diemolding Corp. · Nov 1983