Cleared Traditional

K262547 - KARL STORZ TIPCAM1 Rubina

K262547 is an FDA 510(k) clearance for KARL STORZ TIPCAM1 Rubina, manufactured by KALR STORZ SE & Co. KG. The device is a Class 2 Cardiovascular device with product code OWN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K262547 · KALR STORZ SE & Co. KG · Cardiovascular device
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Sep 2026
Decision
60d
Days
Class 2
Risk

K262547 is an FDA 510(k) clearance for the KARL STORZ TIPCAM1 Rubina. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by KALR STORZ SE & Co. KG (Tuttlingen, DE). The FDA issued a Cleared decision on September 21, 2026 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 876.1500 - 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 KALR STORZ SE & Co. KG devices

FDA 510(k) Submission Details - K262547

510(k) Number K262547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2026
Decision Date September 21, 2026
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWN Device Classification - Class 2, Special Controls

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 Peers - OWN Confocal Optical Imaging

All 62
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