Data / Medical devices / United States / Kemp LLC

Kemp LLC: FDA-registered device maker in Charlotte, NC, United States, 4 510(k) clearances

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

Kemp LLC is registered with the FDA (registration 3005621729) in Charlotte, NC, United States. It lists 17 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 12, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Kemp LLC

FDA registration number: 3005621729
Address: 1900 Bancroft St, Charlotte, NC, United States, 28206
Owner or operator: KEMP LLC (9084061)
Roles: Repackager or relabeler, Specification developer
First device listed: September 23, 2016
Registered through: 2026
Brand names listed: Adhesive Tapes and Bandages For First Aid, Ambu BVM, C Oxygen Tank, D Oxygen Tank, Oxygen Tank Valve Regulator, Cervical Extrication Collars, Cold & Hot Pack For First Aid, Disposable, Dressing, wound, hydrogel without drug and/or biologic, Emerald Nitrile Gloves, Finger Splint, Hand Splint and more

Devices it lists

Device	Product code	Class	Role	Source
Automated External Defibrillators (Non-Wearable)	MKJ	3	Repackager or relabeler	accessdata.fda.gov
Cylinder, Compressed Gas, And Valve	ECX	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Repackager or relabeler	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Repackager or relabeler	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Respirator, Surgical	MSH	2	Repackager or relabeler	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Repackager or relabeler	accessdata.fda.gov
Stretcher, Hand-Carried	FPP	1	Repackager or relabeler	accessdata.fda.gov
Stretcher, Patient Restraint	NZD	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	Repackager or relabeler	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Repackager or relabeler	accessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)	BTM	2	Repackager or relabeler	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
November 12, 2022	K213981	Nitrile Examination Gloves	LZA	Substantially Equivalent	Emerald Glove Manufacturing Sdn Bhd	accessdata.fda.gov
August 29, 2016	K152931	Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator	BTM	Substantially Equivalent	Ambu A/S	accessdata.fda.gov
October 5, 2005	K051632	PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A	MKJ	Substantially Equivalent	Philips Medical Systems	accessdata.fda.gov
March 18, 2005	K042727	POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A	CBP	Substantially Equivalent	Foremount Ent. Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 12, 2022. 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.