Atlas FDA

MicrO2 OSA Device with Micro-Recorder

FDA 510(k) clearance K161624 · decided 2016-11-07

Clearance details

K-number
K161624
Device name
MicrO2 OSA Device with Micro-Recorder
Applicant
Microdental, Inc.
Decision
Substantially Equivalent
Date received
2016-06-13
Decision date
2016-11-07
Days to decision
147 days
Clearance type
Traditional
Product code
PLC
Device class
2
Regulation number
872.5570
Medical specialty
Dental
Advisory committee
Dental
Location
Dublin, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
ProSomnus RPMO2 OSA Device (RPMO2 OSA) (K252765)Prosomnus Sleep Technologies2026-04-06
Rest Assure System (K233497)Somnomed, Inc.2024-10-03
Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (K190353)Residential Home Sleep Services2020-04-10
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (K181571)Mark Abramson, D.D.S., Inc.2019-04-19
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder (K172859)Prosomnous Sleep Technologies2017-11-22
Acrylic Herbst Appliance with Micro-Recorder (K170606)Gergen'S Orthodontic Lab2017-11-16
TAP 3, TAP 1 (K160239)Airway Management, Inc.2016-08-10
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder (K150369)Somnomed, Inc.2015-06-18

Recalls involving this device

No recalls on record reference this clearance.