Cleared Traditional

K944667 - LIFE PULSE TESUSCITATION TIMER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K944667 · Green Field Medical Sourcing, Inc. · Anesthesiology device
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Oct 1994
Decision
14d
Days
Class 1
Risk

K944667 is an FDA 510(k) clearance for the LIFE PULSE TESUSCITATION TIMER. Classified as Cpr Aid Device Without Feedback (product code PMK), Class I - General Controls.

Submitted by Green Field Medical Sourcing, Inc. (Shrewsbury, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.5210 - 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 Green Field Medical Sourcing, Inc. devices

Submission Details

510(k) Number K944667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1994
Decision Date October 04, 1994
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 139d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PMK Cpr Aid Device Without Feedback
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.5210
Definition A Device That Performs A Simple Function Such As Proper Hand Placement And/or Simple Prompting For Rate And/or Timing Of Compressions/breathing For The Professionally Trained Rescuer, But Offers No Feedback Related To The Quality Of The Cpr Being Provided. These Devices Are Intended For Use By Persons Professionally Trained In Cpr To Assure Proper Use And The Delivery Of Optimal Cpr To The Victim.
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.