Cleared Traditional

K851819 - ROKONICS SENTRY MODEL 8500

K851819 is an FDA 510(k) clearance for ROKONICS SENTRY MODEL 8500, manufactured by Rokonics, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K851819 · Rokonics, Inc. · Anesthesiology device
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Jan 1986
Decision
270d
Days
Class 2
Risk

K851819 is an FDA 510(k) clearance for the ROKONICS SENTRY MODEL 8500. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Rokonics, Inc. (Largo, US). The FDA issued a Cleared decision on January 21, 1986 after a review of 270 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K851819

510(k) Number K851819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date January 21, 1986
Days to Decision 270 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 140d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

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 128
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K851819.
AS165 RESPIRATION MONITOR
K861743 · Air-Shields, Inc. · May 1986
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
K860455 · Oxford Medilog, Inc. · Apr 1986
HEALTHDYNE'S EVENT RECORDER SYSTEM
K860254 · Healthdyne, Inc. · Jan 1986
MONAGHAN RVM, MODEL 760 OR MODEL 761
K853047 · Monaghan Medical Corp. · Nov 1985
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K851889 · Clinical Data, Inc. · Oct 1985
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K853084 · Aequitron Medical, Inc. · Aug 1985
K851819 · ROKONICS SENTRY MODEL 8500
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