Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY

K-Number: K852460 · 1985-11-14

ApplicantHealthteam
Decision Date1985-11-14
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY is the device name listed in this FDA 510(k) record. The listed applicant is Healthteam. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K852460. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY?

GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Healthteam. The 510(k) number is K852460.

When did GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY receive FDA 510(k) clearance?

GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY received FDA 510(k) clearance on 1985-11-14, under 510(k) number K852460.

Who is the listed applicant for GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY?

The FDA 510(k) record lists Healthteam as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY?

The FDA product code for GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY is HGX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Healthteam as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K890585INFRARED HEXK890586INFRARED DELUXEK890588GENTLE EXPRESSIONS ELECTRIC BREAST PUMPK852457HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165K852653HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115K852459HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175

View all 8 devices →

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑