510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954438Substantially Equivalent

Sunmed's Greenline Fiber Optic Laryngoscope

Rms Div., Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954438 is the FDA 510(k) clearance record for SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE, a class I device, cleared for Rms Div. on under FDA product code CCW (Laryngoscope, Rigid). FDA records list 10 510(k) clearances for Rms Div., from to . As of , FDA records show no recalls naming K954438.

Clearance record

Decision date
Received
(95 days to decision)
Product code
CCW Laryngoscope, Rigid
Regulation
21 CFR 868.5540
Device class
Class I
Review panel
Anesthesiology
Applicant
Rms Div. 1247 Flordia Ave., Palm Harbor FL
510(k) summary
Statement
Third party review
No

Clearances, product code CCW

Trailing 12 months

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

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