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510(k) K853107

AXICARE CM-14 AUTOMATIC BREAST PUMP by Crystal Medical Products, Inc. — Product Code HGX

K853107 is an FDA 510(k) premarket notification submitted by Crystal Medical Products, Inc. for the device "AXICARE CM-14 AUTOMATIC BREAST PUMP". The FDA issued a decision of Substantially Equivalent on November 19, 1985. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Crystal Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1985
Date Received
July 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Crystal Medical Products, Inc.

  • K861513 — LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP (August 8, 1986)
  • K850753 — NATURAL MOTHER BREAST PUMP (June 7, 1985)
  • K850242 — CRYSTAL MANUAL BREAST PUMP (February 25, 1985)
  • K842766 — CRYSTAL MEDICAL MILK COLLECTION KIT (September 25, 1984)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (September 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 (September 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (September 1, 2026)
  • K260643 — Cimilre Dual Max (August 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (August 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (June 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)

FDA data resources