Atlas FDA

BSR

32 FDA 510(k) clearances · Product code

86 daysmedian time to decision
205 days90th percentile
32clearances measured

FDA profile

Official device name
Stylet, Tracheal Tube
Device class
Class I (low risk)
Regulation
21 CFR 868.5790
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2017: 12 · 2018: 15 · 2019: 18 · 2023: 19 · 2024: 31 · 2025: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip (K162729)Cook Incorporated2017-08-11
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (K962361)Laerdal Medical Corp.1996-09-05
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) (K954771)Laerdal Medical Corp.1996-05-09
MOLLOY INTUBATING STYLETTE (K943104)Molloy Corp.1996-04-18
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (K955238)Rusch Intl.1996-02-06
LIGHTED FLEXGUIDE (MODIFICATION) (K953677)Scientific Sales Intl., Inc.1995-08-25
RUSCH ENDOTRACHEAL TUBE STYLET (K952100)Rusch, Inc.1995-08-08
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (K952266)Stebar Instrument Corp.1995-06-12
AIRGUIDE STYLETTE (K950713)Polamedco, Inc.1995-05-17
FLEXTITIP STYLETTE (K950380)Polamedco, Inc.1995-02-10
STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (K944729)Coast Medical, Inc.1994-12-21
FLEXGUIDE (K940799)Scientific Sales Intl., Inc.1994-08-18
ENDOSTAR(TM) STYLET (K933598)Fiberoptic Medical Products, Inc.1994-01-25
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (K935797)Stebar Instrument Corp.1994-01-12
LIGHTED INTUBATION SYLET (K932081)Aaron Medical, Inc.1993-07-27
WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE (K904999)Opticon Medical, Inc.1993-01-26
STYLET AND TRACHEAL LIGHTWAND (STL) (K922842)Laerdal California, Inc.1992-12-18
ENDOTRACHEAL TUBE STYLET (K921128)Eastmed Enterprises, Inc.1992-06-02
DISPOSABLE STYLETTE WITH END CAP (K914965)Pivic Promedco1992-05-27
AUGUSTINE STYLET (K920468)Augustine Medical, Inc.1992-04-23
AUGUSTINE GUIDE(TM) KIT (K912690)Augustine Medical, Inc.1991-09-04
AUGUSTINE STYLET (K910659)Augustine Medical, Inc.1991-05-17
STYLET TRACHAEL TUBE (K905133)Medical Devices, Inc.1991-04-22
BIVONA ENDOTRACHEAL TUBE STYLET (K905052)Bivona Medical Technologies1991-04-02
TRACHEAL TUBE STYLET (K902180)Sims Surgical, Inc.1990-07-19
N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE (K865108)Ackrad Laboratories1987-02-10
ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE (K844557)Ackrad Laboratories1984-12-17
TUBE-STAT (K843490)Concept, Inc.1984-10-04
SHERI-I-SLIP INTUBATING STYLET (K832773)Sheridan Catheter Corp.1983-09-12
SALEM/RESCE INTUBATION GUIDE (K802416)Scientific Sales Intl., Inc.1980-10-23
INTUBATION PROCEDURE KIT (K772046)American Hospital Supply Corp.1977-11-23
STYLETTE, SLICK, CAT. NO. 2000B (K770374)Medical Products Div. P.O.L.A. Plasti1977-03-30

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Every clearance here is in the API, with alerts when new ones post.