Atlas FDA

Maximus System

FDA 510(k) clearance K200988 · decided 2020-05-26

Clearance details

K-number
K200988
Device name
Maximus System
Applicant
Hill-Rom Services Pte, Ltd.
Decision
Substantially Equivalent
Date received
2020-04-15
Decision date
2020-05-26
Days to decision
41 days
Clearance type
Special
Product code
NHJ
Device class
2
Regulation number
868.5905
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Singapore, SG
Third-party review
No
Expedited review
No

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

RecordFirmDate
KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) (K253001)Hunan Ruijiong Biotech Co., Ltd.2026-06-16
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BiWaze Clear System (K213564)Abmrc, LLC2022-12-21
BiWaze Cough (K191912)Abmrc, LLC2020-03-27
Maximus System (K192143)Hill-Rom Services Pte, Ltd.2020-02-14
MetaNeb 4 System (K151689)Hill-Rom Services Pte, Ltd.2016-03-17
PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (K140598)Dima Italia Srl2014-10-16
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (K140605)Dima Italia Srl2014-10-03
VITAL COUGH (K132988)Lung Assist, Inc.2014-03-28
METANEB (K124032)Hill-Rom Services Pte, Ltd.2013-04-25
COMFORT COUGH (K113549)Seoil Pacific Corp.2013-02-21

Recalls involving this device

RecordFirmDate
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF recall (Z-2548-2026)Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number RE recall (Z-2549-2026)Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number recall (Z-2550-2026)Baxter Healthcare Corporation2026-07-01
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Numbe recall (Z-2551-2026)Baxter Healthcare Corporation2026-07-01
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory recall (Z-1637-2026)Baxter Healthcare Corporation2026-04-01
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SP recall (Z-2321-2024)Baxter Healthcare Corporation2024-07-17
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing de recall (Z-2322-2024)Baxter Healthcare Corporation2024-07-17
In-Line ventilator adaptor recall (Z-1138-2022)Baxter Healthcare Corporation2022-05-30
In-Line ventilator adaptor recall (Z-1139-2022)Baxter Healthcare Corporation2022-05-30