Cleared Traditional

K820059 - RESUSCITATION MASK

K820059 is the FDA 510(k) clearance for RESUSCITATION MASK by Cederroth, Inc. USA. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K820059 · Cederroth, Inc. USA · Anesthesiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Mar 1982

Decision

74d

Days

Class 2

Risk

K820059 is an FDA 510(k) clearance for the RESUSCITATION MASK. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Cederroth, Inc. USA (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Cederroth, Inc. USA devices

Submission Details

510(k) Number	K820059 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 11, 1982
Decision Date	March 26, 1982
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

66d faster than avg

Panel avg: 140d · This submission: 74d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	BTM Ventilator, Emergency, Manual (resuscitator)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.5915

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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 33

Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K820059.

STAT BLUE DISPOS. MANUAL RESUSCITATOR

K850436 · Vital Signs, Inc. · Feb 1985

RESPIRONICS VENTEASY

K842693 · Respironics, Inc. · Aug 1984

CODE BLUE MANUAL RESUSCITATOR

K831885 · Vital Signs, Inc. · Sep 1983

RESUSCITATION CIRCUIT

K812273 · Vital Signs, Inc. · Aug 1981

PMR-2 PURITAN MANUAL RESUSCITATOR

K802813 · Puritan Bennett Corp. · Dec 1980

RESUSCI-BAG-VALVE

K791468 · Concept, Inc. · Aug 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K820059

Cederroth, Inc. USA

Mchenry, IL · US

Regulatory profile

7 submissions 6 cleared

86% clearance rate · Active in Anesthesiology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active