Cleared Traditional

K890227 - SURGICAL PROBE

K890227 is an FDA 510(k) clearance for SURGICAL PROBE, manufactured by Kinetic Medical Products. The device is a Class 1 Orthopedic device with product code HXB cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K890227 · Kinetic Medical Products · Orthopedic device
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Jan 1989
Decision
9d
Days
Class 1
Risk

K890227 is an FDA 510(k) clearance for the SURGICAL PROBE. Classified as Probe (product code HXB), Class I - General Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890227

510(k) Number K890227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date January 27, 1989
Days to Decision 9 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
113d faster than avg
Panel avg: 122d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

HXB Device Classification - Class 1, General Controls

Product Code HXB Probe
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HXB Probe

All 10
Devices cleared under the same product code (HXB) and FDA review panel - the closest regulatory comparables to K890227.
DIAO HAND SURGERY SET
K960539 · Kinetikos Medical, Inc. · Jul 1996
FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
K912843 · Flexmedics · Sep 1991
BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375
K873651 · Arthropedics, Inc. · Nov 1987
HOOK PROBE #TM-1376
K873652 · Arthropedics, Inc. · Nov 1987
2.5MM & 4MM PROBE K841969-LABELING
K841971 · Stainless Mfg., Inc. · Jun 1984
SHUTT PRECISION PROBES
K840558 · Concept, Inc. · Apr 1984