CCJ · Unclassified

3 clearances · 3 unique sponsors

Device class

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Regulation —

Total clearances

2021-06-30 → 2026-05-29

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Sponsor	Clearances	Last 12 mo	Most recent
Carrot, Inc.	1	0	2021-06-30
Bedfont Scientific, Ltd.	1	0	2021-12-21
Capnia, Inc.	1	1	2026-05-29

Pulse

Date	K-number	Sponsor	Device
2026-05-29	K253119	Capnia, Inc.	CoSense ETCO Monitor
2021-12-21	K211918	Bedfont Scientific, Ltd.	iCOquit® Smokerlyzer®
2021-06-30	K201206	Carrot, Inc.	Pivot Breath Sensor