FDA product code HGY: Pump, Breast, Non-Powered
HGY is the FDA product code for pump, breast, non-powered. It is a Class I device, regulated under 21 CFR 884.5150 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 27 510(k) submissions under HGY, from 22 different applicants. The average 510(k) review took 129 days (median 84). FDA has posted 2 recalls for HGY devices.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Breast, Non-Powered |
| Device class | Class I |
| Regulation | 21 CFR 884.5150 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HGY clearance
Top HGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medela, Inc. | 3 | 1995-09-12 |
| Hollister, Inc. | 2 | 2001-08-15 |
| Gerber Products Co. | 2 | 1990-09-26 |
| American Hospital Supply Corp. | 2 | 1981-02-12 |
| Philips Electronics UK Limited | 1 | 2010-11-05 |
17 more applicants have HGY clearances. See the full list in Caduvo.
Most recent HGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101538 | Philips Electronics UK Limited | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) | 2010-11-05 | 155 |
| K032845 | The First Years, Inc. | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 | 2004-04-05 | 207 |
| K013226 | Evenflo Company, Inc. | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | 2001-12-20 | 84 |
| K011519 | Hollister, Inc. | AMEDA HYGIENIKIT | 2001-08-15 | 90 |
| K971231 | White River Concepts | WHITE RIVER MINI MANUAL BREAST PUMP | 1997-05-19 | 46 |
Recalls for HGY devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-12.
Frequently asked questions
What is FDA product code HGY?
HGY is the FDA product code for pump, breast, non-powered. It is a Class I device, regulated under 21 CFR 884.5150 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGY?
Class I, regulation 21 CFR 884.5150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HGY?
Across 27 cleared submissions the average was 129 days from receipt to decision (median 84).
Which companies have the most HGY clearances?
Medela, Inc. (3); Hollister, Inc. (2); Gerber Products Co. (2); American Hospital Supply Corp. (2); Philips Electronics UK Limited (1).
Have HGY devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2015-02-12.
Next steps
- Run an FDA pathway report with predicate devices for product code HGY
- Run a recall and safety report across every HGY manufacturer
- Watch product code HGY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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