Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HGY — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
207 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K101538 | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) | Philips Electronics UK Limited | 2010-11-05 | 155 | 0 |
| K032845 | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 | The First Years, Inc. | 2004-04-05 | 207 | 0 |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Evenflo Company, Inc. | 2001-12-20 | 84 | 0 |
| K011519 | AMEDA HYGIENIKIT | Hollister, Inc. | 2001-08-15 | 90 | 1 |
| K971231 | WHITE RIVER MINI MANUAL BREAST PUMP | White River Concepts | 1997-05-19 | 46 | 0 |
| K962828 | EVERT-IT | Genesis Industries, Inc. | 1997-02-10 | 206 | 0 |
| K952034 | MEDELA'S FOOT PUMP | Medela, Inc. | 1995-09-12 | 134 | 0 |
| K952035 | NIPLETTE | Avent America, Inc. | 1995-07-28 | 88 | 0 |
| K925738 | WHITE RIVER MANUAL BREAST PUMP | White River (Tm) | 1994-05-04 | 537 | 0 |
| K912355 | MOTHERS TOUCH ONE HAND BREAST PUMP | Hollister, Inc. | 1993-12-10 | 927 | 1 |
| K902552 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP | Gerber Products Co. | 1990-09-26 | 110 | 0 |
| K850242 | CRYSTAL MANUAL BREAST PUMP | Crystal Medical Products, Inc. | 1985-02-25 | 34 | 0 |
| K844297 | SUPPLEMENTAL FEEDING SYSTEM | Medela, Inc. | 1985-02-25 | 119 | 0 |
| K843544 | THE BIBICURE SYS BREAST TONER | Les Entreprises Bibi, Inc. | 1985-01-25 | 140 | 0 |
| K840874 | RODY BREAST PUMP | Kean-Rody Manufacturer | 1984-07-23 | 147 | 0 |
| K840325 | INFA COMPLETE BREAST PUMP & MILK STORAG | Monterey Laboratories, Inc. | 1984-03-05 | 40 | 0 |
| K834399 | NEW MOTHER'S WAY-BREAST PUMP | Huntleigh Technology, Inc. | 1984-01-17 | 34 | 0 |
| K833835 | GENTLE FLOW BREAST PUMP | Eklund & Co. | 1983-11-28 | 25 | 0 |
| K831929 | BASIC BREAST PUMP | Terayco Intl., Ltd. | 1983-09-29 | 106 | 0 |
| K832597 | GERBER PRECISION CARE BREAST PUMP | Gerber Products Co. | 1983-09-12 | 41 | 0 |
| K823840 | MEDELA NAMUAL BREAST PUMP | Medela, Inc. | 1983-01-24 | 34 | 1 |
| K823461 | AXIPUMP MANUAL BREAST PUMP | D.J. Colgate Medical, Ltd. | 1983-01-18 | 60 | 0 |
| K823591 | AMEDA HAND BREAST PUMP | Burditt & Calkins-Siemens-Elema | 1982-12-28 | 22 | 0 |
| K822403 | LACT-ASSIST BREAST PUMP | Lact-Assist, Inc. | 1982-09-21 | 42 | 0 |
| K813247 | KANESON/COMFORT PLUS MANUAL BREAST PUMP | Marshall Electronics, Inc. | 1981-12-03 | 15 | 0 |
| K810100 | BREAST PUMP | American Hospital Supply Corp. | 1981-02-12 | 29 | 0 |
| K760911 | BREAST CARE KIT | American Hospital Supply Corp. | 1976-11-11 | 15 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda