Cleared Traditional

K921819 - EDENTEC MODEL 3710 I DIGITAL PRINTER

K921819 is the FDA 510(k) clearance for EDENTEC MODEL 3710 I DIGITAL PRINTER by Edentec Corp.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 555-day FDA review.

K921819 · Edentec Corp. · Anesthesiology device
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Oct 1993
Decision
555d
Days
Class 2
Risk

K921819 is an FDA 510(k) clearance for the EDENTEC MODEL 3710 I DIGITAL PRINTER. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on October 22, 1993 after a review of 555 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Edentec Corp. devices

Submission Details

510(k) Number K921819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1992
Decision Date October 22, 1993
Days to Decision 555 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
415d slower than avg
Panel avg: 140d · This submission: 555d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 36
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K921819.
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MODEL 510 INFANT MONITOR
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MODEL 511 INFANT MONITOR
K942170 · Ge Medical Systems Information Technologies · Jun 1995
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364 · Merit Medical Systems, Inc. · Jan 1993
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K912415 · Medtronic Vascular · Aug 1991
R-BAND(TM) RESPIRATORY SENSOR
K900264 · Buckman Co., Inc. · Jul 1990