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16Ch Flex SPEEDER Pad Kit 72

by Neocoil, LLC

16Ch Flex SPEEDER Pad Kit 72 is a Class II device made by Neocoil, LLC, cleared under FDA 510(k) K121362 on 15 Jun 2012 and listed in FDA GUDID since 16 Mar 2017 (UDI-DI 00856181003725), 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) K121362

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 Number00856181003725 UDI-DI Date16 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121362 Date15 Jun 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121362 decided 15 Jun 2012 Active
  • FDA GUDID UDI-DI 00856181003725 listed 16 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121362
  2. Listed FDA GUDID 00856181003725

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
16Ch Flex SPEEDER Pad Kit
Generic name
MRI system coil, radio-frequency
Model / reference
72
Primary DI / UDI-DI
00856181003725
510(k) Number
FDA product code
MOS
GMDN term
MRI system coil, radio-frequency
Device class
Class II
Regulation number
892.1000
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system coil, radio-frequency

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Other devices filed under MRI system coil, radio-frequency.

Other devices from Neocoil, LLC

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)