Data / Medical devices / United States / Sscor, Inc.

Sscor, Inc.: FDA-registered device maker in Simi Valley, CA, United States, 6 510(k) clearances

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

Sscor, Inc. is registered with the FDA (registration 2022724) in Simi Valley, CA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 18, 2004. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2022724
Address: 2125 N. Madera Rd Unit C, Simi Valley, CA, United States, 93065
Owner or operator: SSCOR, Inc. (10027309)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: October 23, 2008
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer, Specification developer	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	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
May 18, 2004	K041154	S-SCORT...JR QUICKDRAW, MODEL 2400	BTA	Substantially Equivalent	Sscor	accessdata.fda.gov
March 5, 1997	K964997	S-SCORT (2500)	BTA	Substantially Equivalent	Sscor	accessdata.fda.gov
June 16, 1995	K952632	S-SCORT	BTA	Substantially Equivalent	Sscor	accessdata.fda.gov
April 25, 1995	K950464	SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES	GCX	Substantially Equivalent	Sscor	accessdata.fda.gov
December 22, 1994	K945929	S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP	BTA	Substantially Equivalent	Sscor	accessdata.fda.gov
July 24, 1979	K791210	PORTABLE ASPIRATOR	JCX	Substantially Equivalent	Sam Say Assoc.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
January 6, 2005	30845	Not yet classified	Terminated	SSCOR Suction Device Model 2310BV	Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.	accessdata.fda.gov

Compare with other makers

Updated January 27, 2005. 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.