Cleared Traditional

K891540 - EDENTEC MODEL 2860 PRESSURE METER

K891540 is an FDA 510(k) clearance for EDENTEC MODEL 2860 PRESSURE METER, manufactured by Edentec Corp.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K891540 · Edentec Corp. · Anesthesiology device
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Jun 1989
Decision
76d
Days
Class 2
Risk

K891540 is an FDA 510(k) clearance for the EDENTEC MODEL 2860 PRESSURE METER. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on June 1, 1989 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 Edentec Corp. devices

FDA 510(k) Submission Details - K891540

510(k) Number K891540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date June 01, 1989
Days to Decision 76 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
64d faster than avg
Panel avg: 140d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYE Device Classification - Class 2, Special Controls

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 46
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K891540.
DEVILBISS MODEL 7351 SERIES
K894424 · Devilbiss Health Care, Inc. · Sep 1989
CPAP MASK
K894690 · Devilbiss Health Care, Inc. · Sep 1989
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
K893388 · Devilbiss Health Care, Inc. · Jun 1989
MODIFIED SANDERS BI-PAPEASY
K883825 · Respironics, Inc. · Dec 1988
P.E.E.P. VALVE
K882219 · Life Support Products, Inc. · Aug 1988
NASAL CPAP SYSTEM
K881833 · Healthdyne, Inc. · Jun 1988