Cleared Traditional

K083735 - ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS

K083735 is an FDA 510(k) clearance for ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH A..., manufactured by Medtechs, LLC. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K083735 · Medtechs, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
64d
Days
Class 2
Risk

K083735 is an FDA 510(k) clearance for the ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Medtechs, LLC (Durhan, US). The FDA issued a Cleared decision on February 18, 2009 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - the FDA cardiovascular device oversight 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 Medtechs, LLC devices

FDA 510(k) Submission Details - K083735

510(k) Number K083735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2008
Decision Date February 18, 2009
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JOM Device Classification - Class 2, Special Controls

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

All 37
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