Cleared Traditional

K942101 - 4-LEAD IRRIGATION SET

K942101 is an FDA 510(k) clearance for 4-LEAD IRRIGATION SET, manufactured by Douglas Medical Products Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K942101 · Douglas Medical Products Corp. · Orthopedic device
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Sep 1994
Decision
151d
Days
Class 2
Risk

K942101 is an FDA 510(k) clearance for the 4-LEAD IRRIGATION SET. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Douglas Medical Products Corp. (Mundelein, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Douglas Medical Products Corp. devices

FDA 510(k) Submission Details - K942101

510(k) Number K942101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1994
Decision Date September 30, 1994
Days to Decision 151 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 122d · This submission: 151d
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 451
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K942101.
SE5 ARTHROSCOPY SYTEM
K941333 · Stryker Endoscopy · Nov 1994
LIMITED REUSE BLADES
K943985 · Linvatec Corp. · Nov 1994
3M FLUID IRRIGATION SYSTEM
K941388 · 3M Healthcare · Oct 1994
ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS
K940290 · Acufex Microsurgical, Inc. · Sep 1994
CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES
K941036 · Smith & Nephew, Inc. · Sep 1994
MANUAL SURGICAL INSTRUMENTS
K942079 · Acufex Microsurgical, Inc. · Sep 1994