510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950851Substantially Equivalent

Gent-L-Kare Tracheostomy Trays

Premium Plastics, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950851 is the FDA 510(k) clearance record for GENT-L-KARE TRACHEOSTOMY TRAYS, a class I device, cleared for Premium Plastics, Inc. on under FDA product code LRQ (Tracheostomy And Nasal Suctioning Kit). FDA's definition for product code LRQ 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...". FDA records list 9 510(k) clearances for Premium Plastics, Inc., from to . As of , FDA records show no recalls naming K950851.

Clearance record

Decision date
Received
(117 days to decision)
Product code
LRQ Tracheostomy And Nasal Suctioning Kit
Device class
Class I
Review panel
Unknown
Applicant
Premium Plastics, Inc. 465 W. Cermak Rd., Chicago IL
510(k) summary
Summary
Third party review
No

Clearances, product code LRQ

Trailing 12 months

FDA records hold no clearances under product code LRQ in the trailing twelve months.

FDA records show no clearances under product code LRQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260