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510(k) K941524

MODEL 2100 MILD INTERMITTENT SUCTION PUMP by Product & Educational Services — Product Code JCX

K941524 is an FDA 510(k) premarket notification submitted by Product & Educational Services for the device "MODEL 2100 MILD INTERMITTENT SUCTION PUMP". The FDA issued a decision of Substantially Equivalent on May 17, 1994. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Product & Educational Services has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1994
Date Received
March 30, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Product & Educational Services

  • K082850 — EYE SPHERES (February 27, 2009)
  • K941527 — MODEL 2300 GENERAL PURPOSE SUCTION PUMP (May 18, 1994)
  • K941525 — MODEL 2200 THORACIC SUCTION PUMP (May 18, 1994)
  • K941526 — MODEL 2000 MILD INTERMITTENT SUCTION PUMP (May 18, 1994)

Other clearances for product code JCX

  • K250964 — Protable Phlegm Suction Unit (JMA D01) (May 11, 2026)
  • K243638 — MV Flow Aspiration Pump (MVFLOWPMP01) (June 13, 2025)
  • K251111 — Cary (May 7, 2025)
  • K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (December 2, 2024)
  • K233428 — Easycess Aspiration Pump (November 3, 2023)
  • K222552 — 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specime (December 9, 2022)
  • K182950 — Acare Suction Unit (August 23, 2019)
  • K190789 — IntelliCartTM System (April 24, 2019)
  • K190105 — ZOOM Aspiration Pump (February 21, 2019)
  • K180115 — TWBM Pump (July 24, 2018)

FDA data resources