Cleared Traditional

K871621 - THE KARL STORZ MODEL 28805 ARTHRO PUMP

K871621 is the FDA 510(k) clearance for THE KARL STORZ MODEL 28805 ARTHRO PUMP by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K871621 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
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Jun 1987
Decision
39d
Days
Class 2
Risk

K871621 is an FDA 510(k) clearance for the THE KARL STORZ MODEL 28805 ARTHRO PUMP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 39 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K871621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date June 05, 1987
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
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 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K871621.
CONCEPT SUTURE NEEDLE
K874515 · Concept, Inc. · Nov 1987
MODEL 28200C/SHOULDER/ANKLE/ELBOW/HIP/TMJ/SM JOINT
K872986 · KARL STORZ Endoscopy-America, Inc. · Oct 1987
CONCEPT ARTHROSCOPIC PORTAL ROD
K873030 · Concept, Inc. · Sep 1987
SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM
K870915 · C.R. Bard, Inc. · Apr 1987
ELLISON ARTHROSCOPY CHEATER
K864892 · Buckman Co., Inc. · Dec 1986
XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES
K863986 · American Edwards Laboratories · Oct 1986