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510(k) K192143

Maximus System by Hill-Rom Services Pte, Ltd. — Product Code NHJ

K192143 is an FDA 510(k) premarket notification submitted by Hill-Rom Services Pte, Ltd. for the device "Maximus System". The FDA issued a decision of Substantially Equivalent on February 14, 2020. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905. Hill-Rom Services Pte, Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2020
Date Received
August 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Hill-Rom Services Pte, Ltd.

  • K200988 — Maximus System (May 26, 2020)
  • K163378 — Monarch Airway Clearance System (March 17, 2017)
  • K151689 — MetaNeb 4 System (March 17, 2016)
  • K124032 — METANEB (April 25, 2013)

Other clearances for product code NHJ

  • K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) (June 16, 2026)
  • K242438 — Clearo (May 16, 2025)
  • K231728 — BiWaze Clear System (April 8, 2024)
  • K213564 — BiWaze Clear System (December 21, 2022)
  • K200988 — Maximus System (May 26, 2020)
  • K191912 — BiWaze Cough (March 27, 2020)
  • K151689 — MetaNeb 4 System (March 17, 2016)
  • K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (October 16, 2014)
  • K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (October 3, 2014)
  • K132988 — VITAL COUGH (March 28, 2014)

FDA data resources