Atlas FDA

Saans (F4-01-00-000-000)

FDA 510(k) clearance K251165 · decided 2026-01-06

Clearance details

K-number
K251165
Device name
Saans (F4-01-00-000-000)
Applicant
Innaccel Technologies Private Limited
Decision
Substantially Equivalent
Date received
2025-04-15
Decision date
2026-01-06
Days to decision
266 days
Clearance type
Traditional
Product code
SGR
Device class
2
Regulation number
868.5895
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Bengaluru, IN
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun (K250651)Fisher & Paykel Healthcare, Ltd.2025-11-19

Recalls involving this device

No recalls on record reference this clearance.