What is FDA product code KTI?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Inspira AIR · Bronchoscope Accessory → Ear Nose & Throat

Name: Inspira AIR
Brand: Inspira AIR

5manufacturers in China registered for this device type

14catalogue numbers in this listing

2510(k) clearances naming this product code

8recalls on this code

Who Else Makes It

Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KTI
Manufacturer	City	Province	Registered as	Device types
Smartdata Suzhou Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	11
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Alton Shanghai Medical Instruments Co Ltd	Shanghai	Shanghai	Complaint-file establishment	20
BQ Plus Medical Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	13
Dongguan TT Medical, Inc.	Dongguan	Guangdong	Manufacturer	4

Record

Regulatory record for Inspira AIR
Listed by	Acclarent, Inc., United States
FDA product code	KTI
Device type	Bronchoscope Accessory
Device class	Class 2
Regulation	21 CFR 874.4680
Establishment	Specification developer, Manufacturer
510(k)	K090660
Record published	2018-03-31
Record revised	2024-11-21 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Store in a cool, dry place
Packaging	Box of 5

Catalogue Numbers

Catalogue numbers for Inspira AIR
Catalogue number	Size	Status
BC1240AZ		In distribution
BC8524A		In distribution
BC0724A		In distribution
BC1640AZ		In distribution
BC8524AZ		In distribution
BC0524A		In distribution
BC0524AZ		In distribution
BC0724AZ		In distribution
BC1440A		In distribution
BC1040A		In distribution
BC1640A		In distribution
BC1440AZ		In distribution
BC1040AZ		In distribution
BC1240A		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bronchoscope Accessory	Richard Wolf Gmbh	42
MultiStage®	Dongguan TT Medical, Inc.	24
Elation™	Merit Medical Systems, Inc.	23
Texas	Richard Wolf Gmbh	10
Trachealator Non-occlusive Airway Dilation Balloon	Disa Medinotec (PTY) Ltd	9
Pilling	Teleflex Medical LLC	8
CRE Pulmonary	Boston Scientific Corporation	6
Single Use Aspiration Needle	Olympus Medical Systems Corp.	5
Cook	Cook Incorporated	3
Areus(TM) Endobronchial Ultrasound Aspiration Needle	Micro-Tech (Nanjing) Co., Ltd.	3
Trident(TM) Endobronchial Ultrasound Biopsy Needle	Micro-Tech (Nanjing) Co., Ltd.	3
Compass Steerable Needle	Serpex Medical, Inc.	2

Showing 12 of 37. All products under Bronchoscope Accessory

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K110218	2011-03-31
K090660	2009-06-12

Recalls Naming This Product

8 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.

Recalls naming the identifiers of Inspira AIR
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Integra Lifesciences Corporation	UDI-DI	2025-04-04	Class II	Under Investigation by firm	Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.	6 units
Acclarent, Inc.	510(k) number	2013-01-11	Class II	Device Design	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.	1920	2013-10-25
Acclarent, Inc.	510(k) number	2013-01-11	Class II	Device Design	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.	2366	2013-10-25
Acclarent, Inc.	510(k) number	2013-01-11	Class II	Device Design	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.	625	2013-10-25
Acclarent, Inc.	510(k) number	2013-01-11	Class II	Device Design	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.	2703	2013-10-25
Acclarent, Inc.	510(k) number	2013-01-11	Class II	Device Design	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.	1217	2013-10-25
Acclarent, Inc.	510(k) number	2013-01-11	Class II	Device Design	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.	3324	2013-10-25
Acclarent, Inc.	510(k) number	2013-01-11	Class II	Device Design	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.	2175	2013-10-25

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-01-30	Not classified	Component design/selection	Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.	633 units	2013-08-29

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.

Inspira AIR