Data / Medical devices / United States / Medela LLC

Medela LLC: FDA-registered device maker in Mchenry, IL, United States, 26 510(k) clearances

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

Medela LLC is registered with the FDA (registration 1419937) in Mchenry, IL, United States. It lists 19 device types. The FDA files 26 510(k) clearances under its listings, the newest dated April 10, 2026. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1419937
Address: 1101 Corporate DR., Mchenry, IL, United States, 60050
Owner or operator: MEDELA AG (8030974)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: February 25, 1991
Registered through: 2026
Brand names listed: Advanced Personal Double Breastpump, Advanced Personal Double Breastpump; Pump In Style Advanced, BRA COMPRESS, Baby Checker Scale, Babyweigh II scale, Contact Nipple Shield, Enteral Syringe with ENFit Connector, Extension Set and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Holder, Syringe	IQG	1	Specification developer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Repackager or relabeler	accessdata.fda.gov
Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure	PWA	1	Manufacturer	accessdata.fda.gov
Breast Pump Kit	OHH	2	Manufacturer	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Manufacturer, Specification developer	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Nipple, Lambs Feeding	FNN	1	Repackager or relabeler	accessdata.fda.gov
Nursing Pad, Hydrogel	NTC	1	Specification developer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Repackager or relabeler	accessdata.fda.gov
Pump, Breast, Non-Powered	HGY	1	Manufacturer	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Repackager or relabeler	accessdata.fda.gov
Scale, Patient	FRW	1	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Shield, Nipple	HFS	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Manufacturer	accessdata.fda.gov
Unit, Neonatal Phototherapy	LBI	2	Repackager or relabeler	accessdata.fda.gov
Warmer, Thermal, Infusion Fluid	LGZ	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
April 10, 2026	K253510	Freestyle Mini Hands-free	HGX	Substantially Equivalent	Medela, LLC	accessdata.fda.gov
February 13, 2026	K253149	Motion InBra (YM-8801) wearable breast pump	HGX	Substantially Equivalent	Medela, LLC	accessdata.fda.gov
January 22, 2026	K253498	Pump In Style® Pro+	HGX	Substantially Equivalent	Medela, LLC	accessdata.fda.gov
April 12, 2024	K232608	Duo Hands-free Breast Pump	HGX	Substantially Equivalent	Medela, LLC	accessdata.fda.gov
August 11, 2021	K210759	Solo, Swing Maxi	HGX	Substantially Equivalent	Medela, LLC	accessdata.fda.gov
June 15, 2020	K200508	Pump In Style	HGX	Substantially Equivalent	Medela, LLC	accessdata.fda.gov
October 16, 2018	K181937	Pump In Style Advanced, Advanced Personal Double Breastpump	HGX	Substantially Equivalent	Medela, LLC	accessdata.fda.gov
February 15, 2017	K161811	Medela Low Dose Enteral Syringe	PNR	Substantially Equivalent	Medela, Inc.	accessdata.fda.gov
October 28, 2016	K161725	Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail	HGX	Substantially Equivalent	Medela, Inc.	accessdata.fda.gov
September 22, 2016	K162188	Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)	PNR	Substantially Equivalent	Vr Medical Technology	accessdata.fda.gov
June 13, 2013	K122449	ENTERAL NUTRITION WARMER	LGZ	Substantially Equivalent	Acacia, Inc.	accessdata.fda.gov
October 27, 2009	K092986	ACACIA PISTON SYRINGE	FMF	Substantially Equivalent	Acacia, Inc.	accessdata.fda.gov
May 14, 2008	K080328	MPS ACACIA ENTERAL FEEDING TUBE	KNT	Substantially Equivalent	Mps Acacia	accessdata.fda.gov
June 21, 2006	K061205	MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR	BTA	Substantially Equivalent	Medela AG	accessdata.fda.gov
June 8, 2006	K061435	MEDELA VARIO SUCTION PUMPS	OMP	Substantially Equivalent	Medela AG	accessdata.fda.gov
October 15, 2003	K033179	MEDELA CLARIO HOME CARE PUMP	BTA	Substantially Equivalent	Medela AG	accessdata.fda.gov
June 6, 2003	K031614	MEDELA PUMP IN STYLE ADVANCED BREAST PUMP	HGX	Substantially Equivalent	Medela, Inc.	accessdata.fda.gov
May 15, 2002	K021368	MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057	BTA	Substantially Equivalent	Medela AG	accessdata.fda.gov
March 7, 2002	K020518	MEDELA SYMPHONY BREAST PUMP, MODEL 024	HGX	Substantially Equivalent	Medela, Inc.	accessdata.fda.gov
December 12, 1996	K962612	BILIBED PHOTOTHERAPY LAMP	LBI	Substantially Equivalent	Medela, Inc.	accessdata.fda.gov
October 27, 1989	K894206	INTOPO	FMF	Substantially Equivalent	Acacia, Inc.	accessdata.fda.gov
October 6, 1989	K895367	INTRAVENOUS EXTENSION SET	FPA	Substantially Equivalent	Medical Product Specialists	accessdata.fda.gov
April 6, 1988	K875300	MEDELA BREAST-PUMP LACTINA	HGX	Substantially Equivalent	Medela, Inc.	accessdata.fda.gov
August 22, 1985	K853176	CANNON BABYSAFE NIPPLE SHIELDS	HFS	Substantially Equivalent	Medela, Inc.	accessdata.fda.gov
February 25, 1985	K844297	SUPPLEMENTAL FEEDING SYSTEM	HGY	Substantially Equivalent	Medela, Inc.	accessdata.fda.gov
January 24, 1983	K823840	MEDELA NAMUAL BREAST PUMP	HGY	Substantially Equivalent	Medela, 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, 2026	99100	Class II	Ongoing	Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubin	May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.	accessdata.fda.gov
December 2, 2019	84368	Class II	Terminated	Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending o	Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.	accessdata.fda.gov
December 5, 2018	81779	Class III	Terminated	Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100	The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.	accessdata.fda.gov
February 7, 2018	80078	Class II	Terminated	Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model ); b. 15 Days Negative Pressure Wound Therapy (Model ); c. 60 Days Negative Pressure Wound Therapy (Model	Device may display a battery missing error.	accessdata.fda.gov
February 13, 2015	70544	Class II	Terminated	- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo En	The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.	accessdata.fda.gov
July 27, 2011	59453	Not yet classified	Terminated	Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, trans	Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain".	accessdata.fda.gov
May 18, 2011	58730	Not yet classified	Terminated	Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.	accessdata.fda.gov
April 4, 2011	58431	Not yet classified	Terminated	AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. Converting 120 Volt AC power to	The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.	accessdata.fda.gov
January 10, 2011	57597	Not yet classified	Terminated	Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected	The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.	accessdata.fda.gov
August 6, 2010	56498	Not yet classified	Terminated	Sterile double breast personal accessory convenience kit for the Symphony Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclu	The product sterility may be compromised due to possible pinholes in the rigid tray of the package.	accessdata.fda.gov
March 15, 2010	54995	Not yet classified	Terminated	Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for	The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.	accessdata.fda.gov
December 18, 2009	54181	Not yet classified	Terminated	Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte	Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.	accessdata.fda.gov

Compare with other makers

Updated July 1, 2026. 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.