Cleared Traditional

K854817 - INSTAPURE

K854817 is an FDA 510(k) clearance for INSTAPURE, manufactured by Teledyne, Inc.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K854817 · Teledyne, Inc. · General Hospital
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Feb 1986
Decision
87d
Days
Class 2
Risk

K854817 is an FDA 510(k) clearance for the INSTAPURE. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Teledyne, Inc. (Fort Collins, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - the FDA general hospital 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 Teledyne, Inc. devices

FDA 510(k) Submission Details - K854817

510(k) Number K854817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1985
Decision Date February 28, 1986
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRF Device Classification - Class 2, Special Controls

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRF Cleaner, Air, Medical Recirculating

All 20
Devices cleared under the same product code (FRF) and FDA review panel - the closest regulatory comparables to K854817.
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
K974682 · Biological Controls, Inc. · Jan 1998
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NORELCO CLEAN AIR SYSTEM CAS950
K945161 · Hogan & Hartson · Nov 1994
FILTER, PARTICULATE ARRESTING
K760481 · Miles Laboratories, Inc. · Sep 1976