Who else makes this device?

Name: Shape
Brand: Shape

Shape · Calculator, Predicted Values, Pulmonary Function → Anesthesiology

1manufacturer

2catalogue numbers in this listing

2510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code BTY
Manufacturer	City	Province	Registered as	Device types
Guangzhou Homesun Medical Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	4

Record

Regulatory record for Shape
Listed by	Shape Medical Systems, Inc, United States
FDA product code	BTY
Device type	Calculator, Predicted Values, Pulmonary Function
Device class	Class 2
Regulation	21 CFR 868.1890
Establishment	Manufacturer
510(k)	K090722
Record published	2016-09-14
Record revised	2022-03-07 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Shape
Catalogue number	Size	Status
Shape		In distribution
HF012		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Vmax	Carefusion	59
Vmax	Vyaire Medical, Inc.	27
Jaeger	Jaeger Medical GmbH	16
SpiroSphere	eResearchTechnology GmbH	15
Vyaire	Jaeger Medical GmbH	8
Cosmed	C O S M E D SRL	8
MasterScope	eResearchTechnology GmbH	7
Shape-HF	Shape Medical Systems, Inc	3
Avea	Vyaire Medical, Inc.	3
Pneumotach	eResearchTechnology GmbH	2
ERT PT	eResearchTechnology GmbH	2
MasterScreen	Jaeger Medical GmbH	2

Showing 12 of 28. All products under Calculator, Predicted Values, Pulmonary Function

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K150888	2016-01-21
K090722	2009-03-31

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Shape
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Shape Medical Systems, Inc	510(k) number	2014-12-23	Class II	Under Investigation by firm	This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approxi	564 devices	2015-04-14
Shape Medical Systems, Inc	510(k) number	2014-05-28	Class II	Under Investigation by firm	Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could r	800	2015-05-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Shape