Cleared Traditional

K201206 - Pivot Breath Sensor (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence.

K201206 · Carrot, Inc. · Toxicology device
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Jun 2021
Decision
422d
Days
Class 2
Risk

K201206 is an FDA 510(k) clearance for the Pivot Breath Sensor. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Carrot, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 30, 2021 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 868.1430 - the FDA toxicology 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 Toxicology submissions.

View all Carrot, Inc. devices

Submission Details

510(k) Number K201206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2020
Decision Date June 30, 2021
Days to Decision 422 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 87d · This submission: 422d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Toxicology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Jonathan S. Kahan

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.

Clinical Evidence

ClinicalTrials.gov
NCT04133064 Completed Interventional Industry-sponsored

Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study

Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.

234
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Smoking Reduction; Smoking Behaviors; Smoking, Tobacco; Smoking Cessation
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Jen Marler
Sponsor Jennifer Marler, MD (industry)
Started 2019-09-25 → Primary completion 2020-03-10 → Completed 2020-10-01
Primary outcome
Number of Participants With Different Stages of Change in Desire to Quit Smoking
Secondary outcome
Feedback on Breath Sensor Setup, Experience and Use
View full study on ClinicalTrials.gov