510(k) K132220

PJ'S SERENITY by Limerick, Inc. — Product Code HGX

K132220 is an FDA 510(k) premarket notification submitted by Limerick, Inc. for the device "PJ'S SERENITY". The FDA issued a decision of Substantially Equivalent on Feb 20, 2015. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Limerick, Inc. has 3 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: Feb 20, 2015
Date Received: Jul 17, 2013
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: 510(k)

Other clearances for product code HGX

K261782 — MODO DUO Electric Pump (B11621, B11673) (Oct 16, 2026)
K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (Sep 3, 2026)
K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
K260643 — Cimilre Dual Max (Aug 21, 2026)
K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)

510(k) K132220

Clearance Details

Device Classification

Other clearances by Limerick, Inc.

Other clearances for product code HGX

FDA data resources