VectraCor, Inc.

Maple Grove, MN, US

VectraCor, Inc. appears in FDA device records in Maple Grove, MN. FDA records list 10 510(k) clearances between 1998-10-28 and 2018-08-28, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 10
PMA records: 0
Recall records: 1
Registered establishments: 2

FDA records under these names

1 name

FDA records resolved to VectraCor, Inc. 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.

Qrs Diagnostic, LLC510(k), recall

510(k) clearance history

FDA records hold 10 510(k) clearances for VectraCor, Inc. between 1998 and 2018. The busiest year on record is 2000, with 2. The most recent is 2018, with 1.

Clearances by year, as a table

510(k) clearance decisions for VectraCor, Inc., by decision year
Year	Clearances
1998	1
2000	2
2003	2
2008	1
2009	1
2011	1
2015	1
2018	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K173952	Universal SmartECG	DPS	Substantially Equivalent	2018-08-28
K140852	VECTRAPLEX CMS	MSX	Substantially Equivalent	2015-01-30
K102378	VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI	DPS	Substantially Equivalent	2011-11-02
K083749	CARDIOVIEW32 REVIEW MODULE	LOS	Substantially Equivalent	2009-03-10
K073630	MODIFICATION TO: BPCARD, MODEL Z-7000-0700	DXN	Substantially Equivalent	2008-01-11
K031964	BPCARD	DXN	Substantially Equivalent	2003-09-05
K030535	EKGCARD SYSTEM	DPS	Substantially Equivalent	2003-06-11
K001278	SENSAIRE DIAGNOSTIC SPIROMETER	BZG	Substantially Equivalent	2000-11-29
K001995	SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER	DQA	Substantially Equivalent	2000-09-08
K973138	SPIROCARD	BZG	Substantially Equivalent	1998-10-28

Registered establishments

FDA registered establishments for VectraCor, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2133542	1000520092	VectraCor, Inc.	6901 E. Fish Lake Road, Maple Grove, MN 55369 US	2026	BXJ BXW BYP DRX
3009443693	3009443693	VectraCor, Inc.	785 Totowa Rd Suite 100, Totowa, NJ 07512 US	2026	BXJ BXW BZG DPS DQK DRX LOS MHX MLD MSX and 2 more, listed in full below

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-1315-2012	QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.	QRS Diagnostic has initiated a recall involving Universal ECG 12 Lead IEC ECG Devices. This recall has been initiated because the chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretatio		2012-02-16	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 VectraCor, 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