Cleared Traditional

K841971 - 2.5MM & 4MM PROBE K841969-LABELING

K841971 is an FDA 510(k) clearance for 2.5MM & 4MM PROBE K841969-LABELING, manufactured by Stainless Mfg., Inc.. The device is a Class 1 Orthopedic device with product code HXB cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K841971 · Stainless Mfg., Inc. · Orthopedic device
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Jun 1984
Decision
36d
Days
Class 1
Risk

K841971 is an FDA 510(k) clearance for the 2.5MM & 4MM PROBE K841969-LABELING. Classified as Probe (product code HXB), Class I - General Controls.

Submitted by Stainless Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984 after a review of 36 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 Stainless Mfg., Inc. devices

FDA 510(k) Submission Details - K841971

510(k) Number K841971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date June 19, 1984
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
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 K841971.
SURGICAL PROBE
K890227 · Kinetic Medical Products · Jan 1989
BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375
K873651 · Arthropedics, Inc. · Nov 1987
HOOK PROBE #TM-1376
K873652 · Arthropedics, Inc. · Nov 1987
SHUTT PRECISION PROBES
K840558 · Concept, Inc. · Apr 1984
I.M PROBES
K802951 · Hogan & Hartson · Dec 1980
PROBE
K800729 · Stainless Mfg., Inc. · Apr 1980