Century HLM, LLC

Saint Charles, MO, US

Century HLM, LLC appears in FDA device records in Saint Charles, MO. FDA records list one 510(k) clearance, 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: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Century HLM, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Salyer Prn Biomedicalenforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Century HLM, LLC in 2021.

Clearances by year, as a table

510(k) clearance decisions for Century HLM, LLC, by decision year
Year	Clearances
2021	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K202125	Century Perfusion System	DTQ	Substantially Equivalent	2021-03-07

Registered establishments

FDA registered establishments for Century HLM, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3001589655	3001589655	Century HLM, LLC	3551 Somerset Hills Dr, Saint Charles, MO 63303 US	2026	DTQ DWB

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0902-2013	Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.	Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.	Class II	2013-01-31	Terminated

Verification record

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