Lansinoh Laboratories Inc

Alexandria, VA, US

LANSINOH LABORATORIES, INC. appears in FDA device records in Alexandria, VA. FDA records list 2 510(k) clearances between 2022-12-23 and 2023-06-30, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Lansinoh Laboratories Inc between 2022 and 2023. The busiest year on record is 2022, with 1. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Lansinoh Laboratories Inc, by decision year
Year	Clearances
2022	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K230469	Compact Wearable Pump	HGX	Substantially Equivalent	2023-06-30
K222726	Smartpump 3.0 Double Electric Breast Pump	HGX	Substantially Equivalent	2022-12-23

Registered establishments

FDA registered establishments for Lansinoh Laboratories Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2032361	3022898	LANSINOH LABORATORIES, INC.	99 Canal Center Plaza, Alexandria, Suite 550, ALEXANDRIA, VA 22314 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

HGXPump, Breast, Powered

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0784-2013	THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.	The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.	Class II	2012-08-14	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Lansinoh Laboratories Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain