Cleared Traditional

K875077 - HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.

K875077 is an FDA 510(k) clearance for HERCO SILICONE RESUSCITATOR OR SUN-MED ..., manufactured by Herco Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K875077 · Herco Products, Inc. · Anesthesiology device
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Jan 1988
Decision
41d
Days
Class 2
Risk

K875077 is an FDA 510(k) clearance for the HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Herco Products, Inc. (Toledo, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 41 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.

FDA 510(k) Submission Details - K875077

510(k) Number K875077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date January 19, 1988
Days to Decision 41 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 140d · This submission: 41d
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 164
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K875077.
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K883434 · Ambu, Inc. · Sep 1988
NONREBREATHING CIRCUIT
K882285 · Dryden Corp. · Aug 1988
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K874418 · Life Support Products, Inc. · Jan 1988
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K873286 · Hospitak, Inc. · Oct 1987
PULMANEX TM (MODIFICATION)
K863026 · Life Design Systems, Inc. · Aug 1986
PULMANEX (TM)
K860693 · Life Design Systems, Inc. · Mar 1986
K875077 · HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.
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