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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Patient Isolation
510(k) Number K260180
Device Name Carecube Negative Pressure Isolation Chamber (1BY)
Applicant
Carecubes, Inc.
3101 20th St.
San Francisco,  CA  94110
Applicant Contact Steve Bollinger
Correspondent
Sol MedTech Compliance, LLC
3547 Cherry Blossom Ct.
Unit 202
Estero,  FL  33928
Correspondent Contact Niki Spaniel
Regulation Number880.5450
Classification Product Code
LGM  
Date Received01/21/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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