FDA product code · Obstetrics/Gynecology
HGXPump, Breast, Powered
Product code HGX covers Pump, Breast, Powered, a Class II device regulated under 21 CFR 884.5160. FDA has cleared 248 devices in this code, 43 of them in the last 12 months. Median review time across the 248 most recent decisions is 145 days. openFDA lists 8 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 884.5160
- Review panel
- Obstetrics/Gynecology
- Clearances
- 248
What is happening in HGX right now?
HGX (Pump, Breast, Powered) has two findings, most consequential first. 5 first-time filers in the last 12 months, including Shenzhen Qinyi Electronic Technology Co., Ltd. and Polybell (Guangzhou) Limited (K261025, K260346, K250129, K253072, K250207). The code is crowded, scoring 91 of 100 — 102 companies hold a clearance here and 43 arrived in the last 12 months (HGX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K261025, K260346, K250129, K253072, K250207 |
| Crowding | Context | HGX:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in HGX?
FDA has cleared 248 devices under product code HGX since the 510(k) programme began in 1976, 43 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. | |
| K261199 | Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. | |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | Shenzhen Root Innovation Technology Co., Ltd. | |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | Shenzhen Root Innovation Technology Co., Ltd. | |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) | Polybell (Guangzhou) Limited | |
| K250129 | AViTA Breast Pump | Avita Corporation | |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. | |
| K260956 | Spectra Platinum Mini | Uzinmedicare Co., Ltd. |
How long does FDA review take for HGX?
The median FDA review time for HGX is 145 days, measured across the 248 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in HGX?
openFDA lists 8 recall records against product code HGX. A recall record covers one firm's corrective action and may span many device lots.
Z-0616-2018Open, ClassifiedAmeda, Inc.
Two specific lots was incorrectly manufactured containing a UK power adapter.
Z-1336-2014TerminatedEnergizer Personal Care
Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.
Z-1224-2011TerminatedMedela Inc
The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.
Z-2483-2010TerminatedMedela Inc
The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Z-2484-2010TerminatedMedela Inc
The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Showing the 5 most recently initiated of 8. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for HGX?
MAUDE holds 330 adverse-event reports naming product code HGX, 21 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in HGX unusual?
Every month with enough history behind it falls inside HGX's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 14 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 7 | 0–18 | Within expected (0–18) | |
| 3 | 0–15 | Within expected (0–15) | |
| 9 | 0–16 | Within expected (0–16) | |
| 7 | 0–17 | Within expected (0–17) | |
| 11 | 0–15 | Within expected (0–15) | |
| 3 | 0–17 | Within expected (0–17) | |
| 7 | 3–18 | Within expected (3–18) | |
| 6 | 1–13 | Within expected (1–13) | |
| 5 | 1–13 | Within expected (1–13) | |
| 2 | 0–13 | Within expected (0–13) | |
| 1 | 0–11 | Within expected (0–11) | |
| 3 | 0–12 | Within expected (0–12) | |
| 3 | 0–13 | Within expected (0–13) | |
| 3 | Insufficient history | No expected range — too little history |
22 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in HGX.
Who has entered HGX in the last year?
5 companies filed in HGX for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Shenzhen Qinyi Electronic Technology Co., Ltd. | K261025 | |
| Polybell (Guangzhou) Limited | K260346 | |
| Avita Corporation | K250129 | |
| Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. | K253072 | |
| Anker Innovations Limited | K250207 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in HGX?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in HGX?
Across the 248 most recent decisions, these applicants filed most often in HGX.
| Applicant | Recent clearances |
|---|---|
| Shenzhen TPH Technology Co., Ltd. | 23 |
| Shenzhen Root Innovation Technology Co., Ltd. | 10 |
| Medela, Inc. | 7 |
| Medela, LLC | 7 |
| Evenflo Company, Inc. | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
4 companies in HGX file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Medela Inc | 19 | 3 |
| Uzinmedicare Co., Ltd. | 12 | 3 |
| Shenzhen Root Innovation Technology Co., , Ltd. | 11 | 2 |
| Evenflo Company, Inc. | 9 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch HGX
Get an email the morning anything changes in HGX — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.