Data / Medical devices / United States / Microspecialties LLC

Microspecialties LLC: FDA-registered device maker in Middletown, CT, United States, 7 510(k) clearances

Name: Microspecialties LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Microspecialties LLC is registered with the FDA (registration 1226074) in Middletown, CT, United States. It lists 14 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 26, 2010. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 1226074
FEI number: 3002616700
Address: 430 Smith St, Middletown, CT, United States, 06457
Owner or operator: MICROSPECIALTIES LLC (10053719)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed: January 4, 2017
Registered through: 2026
Brand names listed: COMFORTEAR PUNCTUM PLUG, Fixator, Keratome Blade, MICROKARE Knife, MICROkeratome Tubing, MK800800 (Plano-10,-20,-30,-40) Calibrated Nidek Blades MK101101 (Plano, -10,-20,-30,-40,+10,+20) Calibrated XP Blade, PRO EYE SHIELD, PRO MARKING PEN and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Repackager or relabeler	accessdata.fda.gov
Collagen Corneal Shield	MOE	1	Repackager or relabeler	accessdata.fda.gov
Drape, Patient, Ophthalmic	HMT	2	Repackager or relabeler	accessdata.fda.gov
Eye Tray	OJK	2	Manufacturer	accessdata.fda.gov
Keratome, Ac-Powered	HNO	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Manufacturer	accessdata.fda.gov
Marker, Ocular	HMR	1	Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Repackager or relabeler	accessdata.fda.gov
Plug, Punctum	LZU	U	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Repackager or relabeler	accessdata.fda.gov
Sponge, Ophthalmic	HOZ	2	Repackager or relabeler	accessdata.fda.gov
Surgical Eye Tray	PZG	1	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 26, 2010	K093753	MDPO FRAME SYSTEM	KTT	Substantially Equivalent	Mdpo, LLC	accessdata.fda.gov
August 19, 2005	K050851	DELTA PUNCTUM PLUG	LZU	Substantially Equivalent	Delta Life Science, Inc.	accessdata.fda.gov
May 25, 2004	K033457	M2 COMPATIBLE MICROKERATOME BLADE	HNO	Substantially Equivalent	Micro Specialties, Inc.	accessdata.fda.gov
December 16, 2002	K020482	KERATOME BLADE 200200 & 600600	HNO	Substantially Equivalent	Micro Specialties, Inc.	accessdata.fda.gov
November 6, 2001	K011195	PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB	HNO	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.	accessdata.fda.gov
March 15, 2000	K994015	ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508	HNO	Substantially Equivalent	Surgin Surgical Instrumentation, Inc.	accessdata.fda.gov
May 1, 1998	K980510	KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)	HNO	Substantially Equivalent	Micro Specialties, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 5, 2024	94794	Class II	Ongoing	Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060	Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.	accessdata.fda.gov

Compare with other makers

Updated July 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.