FDA product code HDB: Extractor, Vacuum, Fetal
HDB is the FDA product code for extractor, vacuum, fetal. It is a Class II device, regulated under 21 CFR 884.4340 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 30 510(k) submissions under HDB, 1 in the last five years, from 17 different applicants. The average 510(k) review took 141 days (median 98); 250 days on average over the last three years. FDA has posted 6 recalls for HDB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Extractor, Vacuum, Fetal |
| Device class | Class II |
| Regulation | 21 CFR 884.4340 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HDB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 250 |
Compare with all 510(k) review times · Search every HDB clearance
Top HDB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neward Enterprises, Inc. | 5 | 1996-08-29 |
| Swift Delivery Products | 3 | 2002-01-17 |
| Challenge Mfg., Inc. | 3 | 1989-11-27 |
| Prism Enterprises, Inc. | 2 | 2002-04-12 |
| Hollister, Inc. | 2 | 1998-08-21 |
12 more applicants have HDB clearances. See the full list in Caduvo.
Most recent HDB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250298 | Clinical Innovations, LLC | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) | 2025-10-08 | 250 |
| K041579 | Medela AG | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | 2005-04-21 | 311 |
| K043614 | Medevco, Inc. | VACULINK, MODEL VCL 3000 | 2005-04-14 | 105 |
| K021193 | Fortune Medical Instrument Corp. | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | 2003-02-12 | 303 |
| K020447 | Prism Enterprises, Inc. | MITYVAC MERLIN, MODEL 10027 | 2002-04-12 | 60 |
Recalls for HDB devices
6 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-03-09.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HDB?
HDB is the FDA product code for extractor, vacuum, fetal. It is a Class II device, regulated under 21 CFR 884.4340 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDB?
Class II, regulation 21 CFR 884.4340. Typical premarket route: 510(k).
How long does a 510(k) take for product code HDB?
Across 30 cleared submissions the average was 141 days from receipt to decision (median 98).
Which companies have the most HDB clearances?
Neward Enterprises, Inc. (5); Swift Delivery Products (3); Challenge Mfg., Inc. (3); Prism Enterprises, Inc. (2); Hollister, Inc. (2).
Have HDB devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2026-03-09.
Next steps
- Run an FDA pathway report with predicate devices for product code HDB
- Run a recall and safety report across every HDB manufacturer
- Watch product code HDB 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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