Cleared Traditional

EDWARDS ARTHROSCOPIC LEG HOLDER (K884302) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884302 · Baxter Healthcare Corp · Orthopedic device
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Nov 1988
Decision
48d
Days
Class 2
Risk

K884302 is an FDA 510(k) clearance for the EDWARDS ARTHROSCOPIC LEG HOLDER. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on November 30, 1988 after a review of 48 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K884302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1988
Decision Date November 30, 1988
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 157
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K884302.
POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES
K904720 · Baxter Healthcare Corp · Oct 1990
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)
K901617 · Smith & Nephew, Inc. · May 1990
EDWARDS DISPOSABLE ARTHROSCOPY CANNULA
K884301 · Baxter Healthcare Corp · Mar 1989
28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES
K881715 · KARL STORZ Endoscopy-America, Inc. · Aug 1988
3M CARPAL TUNNEL
K881703 · 3M Company · Jul 1988
EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES
K880205 · Baxter Healthcare Corp · Feb 1988