Cleared Traditional

K823848 - CRAFTON ARTHROSCOPY PUMP AP-10

K823848 is an FDA 510(k) clearance for CRAFTON ARTHROSCOPY PUMP AP-10, manufactured by Gambro, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K823848 · Gambro, Inc. · Orthopedic device
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Mar 1983
Decision
77d
Days
Class 2
Risk

K823848 is an FDA 510(k) clearance for the CRAFTON ARTHROSCOPY PUMP AP-10. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Gambro, Inc. (Walker, US). The FDA issued a Cleared decision on March 8, 1983 after a review of 77 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K823848

510(k) Number K823848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date March 08, 1983
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K823848.
PATELLAR FAT PAD RETRACTOR
K831248 · Techmedica, Inc. · Jun 1983
CRAFON ARTHROSCOPY LINES
K830673 · Gambro, Inc. · Jun 1983
ESA ELECTROSURGICAL ARTHROSCOPY GENERA
K830499 · Concept, Inc. · Mar 1983
ESA ARTHROSCOPY CANNULA TRAY
K823832 · Concept, Inc. · Feb 1983
PROFLEX
K821672 · Utah Medical Products, Inc. · Jul 1982
I.M. ARTHROSCOPE
K821847 · Instrument Makar, Inc. · Jul 1982