Atlas FDA

CCW

64 FDA 510(k) clearances · Product code

87 daysmedian time to decision
290 days90th percentile
64clearances measured

FDA profile

Official device name
Laryngoscope, Rigid
Device class
Class I (low risk)
Regulation
21 CFR 868.5540
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 437 · 2022: 324 · 2023: 346 · 2024: 473 · 2025: 1,578 · 2026: 584
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
APA Oxy Blade (K191602)Venner Medical (Singapore) Pte, Ltd.2019-08-02
Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (K163412)Girgis Scope, LLC2017-06-22
YEESCOPE LARYNGOSCOPES (K140951)Yeescope Pty. , Ltd.2014-11-10
AIRTRAQ SP AIRTRAQ AVANT (K121378)Prodol Meditec , Ltd.2012-06-21
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (K063477)Novamed, LLC2007-02-09
TRU-MR LARYNGOSCOPE SET (K062523)Truphatek International, Ltd.2006-11-17
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (K062230)Minrad, Inc.2006-08-31
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (K062231)Minrad, Inc.2006-08-31
MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (K041852)Minrad, Inc.2004-11-15
FLEXIBLADE (K984101)Arco Medic , Ltd.1999-09-03
GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE (K971377)Wilson Greatbatch Technologies, Inc.1998-04-30
GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE (K970619)Wilson Greatbatch Technologies, Inc.1997-11-19
SCOPETEX(TM) (K945590)Smith Helms Mulliss & Moore, L.L.P.1997-05-20
BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER (K961832)Blue Ridge Medical, Inc.1996-09-06
LARYNGOSCOPE COVER (K945301)Sotiria Mourkidou, M.D.1996-05-31
ILLUMINATOR (K954787)Hospitak, Inc.1996-01-31
SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE (K954438)Rms Div.1995-12-29
AUGUSTINE INTUBATION GUIDE (K954446)Augustine Medical, Inc.1995-12-29
CLM LARYNGOSCOPE (K953179)Penlon , Ltd.1995-10-06
LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER (K951147)Leigh Med Tech, Inc.1995-06-08
KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE (K951804)KARL STORZ Endoscopy-America, Inc.1995-06-05
MCINTOSH, MILLER, FOREGGER BABY (K945425)Rudolf Riester GmbH & Co. KG1995-03-20
DIRECT VIEW 2001 FIBERLIGHT (K945901)Mercury Medical1994-12-27
LITE-BLADE (K944428)Eare Consulting Service1994-11-15
OPTUS LARYNGOSCOPES (K945269)Optus, Inc.1994-11-07
FIBEROPTIC LARYNGOSCOPE HANDLE (K944686)Fiberoptic Medical Products, Inc.1994-11-04
THE WUSCOPE SYSTEM (K941319)Achi Corp.1994-10-04
FILLISCOPE (K930804)Filliscope, Inc.1993-10-07
SUNLITE LARYNGOSCOPE (K921263)Sunmed, Inc.1993-06-01
SLATER SLEEVE (K926158)Tadco, Inc.1993-03-19
LARYNGOSCOPE RIGID (K922019)Eastmed Enterprises, Inc.1993-01-26
UPSHERSCOPE(TM) (K922275)Upsher Laryngoscope Co.1993-01-06
AUGUSTINE FIBEROPTIC LARYNGOSCOPE (K915161)Augustine Medical, Inc.1992-05-29
AUGUSTINE GUIDE KIT (K921166)Augustine Medical, Inc.1992-04-23
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES (K905273)Vital Signs, Inc.1992-03-24
PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. (K915804)Propper Mfg. Co., Inc.1992-03-20
AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED (K914741)Eastmed Enterprises, Inc.1992-02-03
AUGUSTINE GUIDE KIT WITH GAUZE SPONGE (K914168)Augustine Medical, Inc.1991-10-07
LARYNGOSCOPE (K912905)Acorn Group, Inc.1991-09-30
BELSCOPE LARYNGOSCOPE (K904918)Avulunga Pty. , Ltd.1991-07-22
NEUSTEIN LARYNGOSCOPE (K901164)Neutech Corp.1990-10-09
BAUMAN RIGID LARYNGOSCOPE (K901680)Palex Intl. SA1990-07-12
MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) (K901489)Eastmed Enterprises, Inc.1990-04-10
LARYNGOSTAT LARYNGOSCOPE HANDLE (K895954)Michigan Instruments, Inc.1989-10-30
FIBER OPTIC LARYNGOSCOPE (K883830)Effner, Inc.1988-10-25
BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P (K883819)Circon Acmi1988-10-17
LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) (K884073)Eastmed Enterprises, Inc.1988-10-13
LARYNGOSCOPE (K883296)Lothar Scharras1988-10-13
LARYNGOSCOPE RIGID (K882433)Eastmed Enterprises, Inc.1988-09-02
LARYNGOSCOPE BLADES (K883414)Truphatek, Ltd.1988-08-19
LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX (K882930)Pilling Co.1988-08-16
AUGUSTINE INTUBATION GUIDE(TM) (K882659)Augustine Medical, Inc.1988-07-21
KAHN-TACT U.S.A., EFF LARYNGOSCOPE (K872480)Effner and Spreine Co.1987-08-10
LIBAN INTUBATOR (K861026)Life Support Devices Co.1986-07-28
EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN (K844776)Medical Instruments and Lamps1985-10-01
LARYNGOSCOPE (K851705)Armstrong Ind., Inc.1985-05-21
D.L. SCOPE BLADE & HANDLE (K841778)North American Medical Products, Inc.1984-05-23
LARYNGOSCOPE BLADES/HANDLES & LAMPS (K833055)Medovations, Inc.1983-11-14
DISPOSA-LITE LARYNGOSCOPE BLADE (K832984)Michael S. Upsher1983-10-28
DISPOSBLADE LARYNGOSCOPE (K833133)Geller & Bozeman1983-10-27
LARYNGESCOPE (K831981)W.E. Leder Enterprises, Inc.1983-09-29
UPSHER FIBERBRITE LARYNGOSCOPE (K832650)Michael S. Upsher1983-09-12
FIBER OPTIC LARYNGOSCOPES W/BATTERY (K830047)Welch Allyn, Inc.1983-01-18
OROTRACHEAL INTUBATION ENDOSCOPE (K801452)Olympus Corp.1980-07-14

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