Cleared Traditional

K160610 - Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set

K160610 is an FDA 510(k) clearance for Kobold Fletcher-model Tandem and Ovoid ..., manufactured by Kobold, LLC. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K160610 · Kobold, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
347d
Days
Class 2
Risk

K160610 is an FDA 510(k) clearance for the Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model .... Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Kobold, LLC (Veradale, US). The FDA issued a Cleared decision on February 13, 2017 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - the FDA radiology and imaging software 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K160610

510(k) Number K160610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2016
Decision Date February 13, 2017
Days to Decision 347 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 107d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 Radiology devices follow this clearance model.

Regulatory Consultant

Bb Medical Surgical, Inc.
Christina Bernstein

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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 189
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