Cleared Traditional

K132883 - HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)

K132883 is an FDA 510(k) clearance for HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS), manufactured by Hemodia Sas. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K132883 · Hemodia Sas · Orthopedic device
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Nov 2013
Decision
49d
Days
Class 2
Risk

K132883 is an FDA 510(k) clearance for the HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS). Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Hemodia Sas (Labege, FR). The FDA issued a Cleared decision on November 1, 2013 after a review of 49 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 Hemodia Sas devices

FDA 510(k) Submission Details - K132883

510(k) Number K132883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2013
Decision Date November 01, 2013
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Pharmalink Technical Group, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRX Arthroscope

All 573
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