Cleared Traditional

K842487 - SAMSON'S NEWBORN LUNG INFLATOR 340-1000

K842487 is an FDA 510(k) clearance for SAMSON'S NEWBORN LUNG INFLATOR 340-1000, manufactured by J. H. Emerson Co.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K842487 · J. H. Emerson Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
10d
Days
Class 2
Risk

K842487 is an FDA 510(k) clearance for the SAMSON'S NEWBORN LUNG INFLATOR 340-1000. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by J. H. Emerson Co. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 10 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 J. H. Emerson Co. devices

FDA 510(k) Submission Details - K842487

510(k) Number K842487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date July 06, 1984
Days to Decision 10 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
130d faster than avg
Panel avg: 140d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

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 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K842487.
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436 · Vital Signs, Inc. · Feb 1985
FLOW CONTROLLER
K843223 · Precision Medical, Inc. · Sep 1984
RESPIRONICS VENTEASY
K842693 · Respironics, Inc. · Aug 1984
MARK III RESUSCITATOR
K840349 · Ambu, Inc. · Feb 1984
CODE BLUE MANUAL RESUSCITATOR
K831885 · Vital Signs, Inc. · Sep 1983
SC-603 TWIN VALVE
K831486 · Instrumentation Industries, Inc. · Aug 1983