Atlas FDA

CAL

8 FDA 510(k) clearances · Product code

21 daysmedian time to decision
172 days90th percentile
8clearances measured

FDA profile

Official device name
Laryngoscope, Non-Rigid
Device class
Class I (low risk)
Regulation
21 CFR 868.5530
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 60 · 2022: 258 · 2023: 268 · 2024: 204 · 2025: 87 · 2026: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
FI-10P (K951195)Pentax Precision Instrument Corp.1995-04-06
FI-10M (K951194)Pentax Precision Instrument Corp.1995-04-06
HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. (K872895)Haemonetics Corp.1988-01-11
REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 (K852994)Reichert-Jung, Inc.1985-07-29
OLYMPUS LF-1 INTUBATION SCOPE (K850978)Olympus Corp.1985-05-23
AO FLEXIBLE LARYNGOSCOPE, #LS-7 (K802331)American Optical Corp.1980-10-10
AO STYLET LARYNGOSCOPE MODEL SLS (K801364)American Optical Corp.1980-06-17
AO STYLET LARYNGOSCOPE, MODEL SLS-1 (K791634)American Optical Corp.1979-09-17

Track CAL automatically

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