Cleared Traditional

K102047 - LCI OPTION FOR INNOCOR

K102047 is an FDA 510(k) clearance for LCI OPTION FOR INNOCOR, manufactured by Innovision A/S. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 468-day FDA review.

K102047 · Innovision A/S · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
468d
Days
Class 2
Risk

K102047 is an FDA 510(k) clearance for the LCI OPTION FOR INNOCOR. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Innovision A/S (Lake Bluff, US). The FDA issued a Cleared decision on November 1, 2011 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K102047

510(k) Number K102047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2010
Decision Date November 01, 2011
Days to Decision 468 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
328d slower than avg
Panel avg: 140d · This submission: 468d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZC Calculator, Pulmonary Function Data

All 53
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