Cleared Traditional

K821672 - PROFLEX

K821672 is an FDA 510(k) clearance for PROFLEX, manufactured by Utah Medical Products, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K821672 · Utah Medical Products, Inc. · Orthopedic device
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Jul 1982
Decision
43d
Days
Class 2
Risk

K821672 is an FDA 510(k) clearance for the PROFLEX. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Utah Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K821672

510(k) Number K821672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1982
Decision Date July 22, 1982
Days to Decision 43 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 122d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K821672.
ESA ELECTROSURGICAL ARTHROSCOPY GENERA
K830499 · Concept, Inc. · Mar 1983
CRAFTON ARTHROSCOPY PUMP AP-10
K823848 · Gambro, Inc. · Mar 1983
ESA ARTHROSCOPY CANNULA TRAY
K823832 · Concept, Inc. · Feb 1983
I.M. ARTHROSCOPE
K821847 · Instrument Makar, Inc. · Jul 1982
ARTHROSCOPES & ASSOCIATED INSTRUMENTS
K821359 · Downs Surgical , Ltd. · May 1982
MINI-MICRO ARTHROSCOPIC SCAPEL
K820777 · The Anspach Effort, Inc. · May 1982