510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850437Substantially Equivalent

Disposable Laryngoscope

Vital Signs, Inc., Totowa NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850437 is the FDA 510(k) clearance record for DISPOSABLE LARYNGOSCOPE, a class II device, cleared for Vital Signs, Inc. on under FDA product code LLW (Laser, Neodymium:Yag For Gynecologic Use). FDA records list 75 510(k) clearances for Vital Signs, Inc., from to . As of , FDA records show no recalls naming K850437.

Clearance record

Decision date
Received
(9 days to decision)
Product code
LLW Laser, Neodymium:Yag For Gynecologic Use
Regulation
21 CFR 884.4550
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Vital Signs, Inc. 20 Campus Rd., Totowa NJ
Third party review
No

Clearances, product code LLW

Trailing 12 months

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

FDA records show no clearances under product code LLW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LLW, 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