510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LRQClass I

Tracheostomy And Nasal Suctioning Kit

Unknown
FDA source (opens on fda.gov)

LRQ is the FDA product code for Tracheostomy And Nasal Suctioning Kit, a class I device type. FDA's definition for this code reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
LRQ
Device name
Tracheostomy And Nasal Suctioning Kit
FDA definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Device class
Class I
Review panel
Unknown
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
4

Clearances, product code LRQ

By decision year
6 clearances under product code LRQ with a decision year between 1986 and 1996, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LRQ by decision year
YearClearances
19861
19871
19952
19962

Applicants with the most clearances

Product code LRQ
Applicants holding the most 510(k) clearances under product code LRQ
ApplicantClearances
Automatic Liquid Packaging, Inc.1
Contour Fabricators of Florida, Inc.1
Grand Medical Products1
Medcare Medical Group, Inc.1
Premium Plastics, Inc.1
Welmed Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order