Firstkind Limited

FDA Regulatory Profile

Firstkind Limited has 0 FDA recalls, 1 inspection, 12 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 12, 2016 · NAI
Latest 510(k)
Mar 4, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances12Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 12, 2016High Wycombe, United KingdomDevicesNo Action Indicated (NAI)3011197543

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K220327geko W-3Mar 4, 2022
K212762geko W-2Nov 29, 2021
K201131firefly T-2May 28, 2020
K193045geko™ W-2Jan 18, 2020
K191113geko T-2 and geko T-3 Neuromuscular StimulatorsSep 18, 2019
K181059geko T-3 Neuromuscular StimulatorMay 23, 2018
K180082geko T-2 and geko Plus R-2Feb 11, 2018
K163125geko™ T-2 and geko™ Plus R-2 Neuromuscular StimulatorsApr 10, 2017
K160299geko(TM) Plus R-2 Neuromuscular StimulatorApr 8, 2016
K152677geko T-2 Neuromuscular StimulatorOct 23, 2015
K133638GEKOAug 21, 2014
K134001FIREFLYMay 15, 2014