Cleared Traditional

Tempo Smart Button (K212217) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212217 · Eli Lilly and Company · General Hospital
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Sep 2022
Decision
427d
Days
Class 2
Risk

K212217 is an FDA 510(k) clearance for the Tempo Smart Button. Classified as Injection Data Capture Device (product code QOG), Class II - Special Controls.

Submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on September 16, 2022 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 General Hospital submissions.

View all Eli Lilly and Company devices

Submission Details

510(k) Number K212217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2021
Decision Date September 16, 2022
Days to Decision 427 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
298d slower than avg
Panel avg: 129d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QOG Injection Data Capture Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition An Injection Data Capture Device Is An Electrically-powered/electromechanical Accessory That Interfaces With Reusable Or Disposable Injection Devices For The Purposes Of Interpreting, Recording And Displaying And/or Transmitting Injection Data To A Connected Application Or Software.
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 General Hospital devices follow this clearance model.