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Propeller Sensor Model 2016-M-L

by Reciprocal Labs

Propeller Sensor Model 2016-M-L is an inhaler dose sensor (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Reciprocal Labs, cleared under FDA 510(k) K142516 on 15 May 2015 and listed in FDA GUDID since 21 Dec 2017 (UDI-DI 00865528000082), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K142516

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00865528000082 UDI-DI Date21 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142516 Date15 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142516 decided 15 May 2015 Active
  • FDA GUDID UDI-DI 00865528000082 listed 21 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142516
  2. Listed FDA GUDID 00865528000082

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Propeller
Generic name
Inhaler dose sensor
Model / reference
Sensor Model 2016-M-L
Primary DI / UDI-DI
00865528000082
510(k) Number
FDA product code
CAF
GMDN term
Inhaler dose sensor
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Inhaler dose sensor

Cleared under the same submission (K142516)

Similar devices

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

Other devices from Reciprocal Labs

See all devices from Reciprocal Labs →

Properties

  • Single use
  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)