Data / Medical devices / Resuscitator, Manual, Non Self-Inflating
Resuscitator, Manual, Non Self-Inflating (NHK): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Resuscitator, Manual, Non Self-Inflating (product code NHK, Class 2, 21 CFR 868.5905). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on November 23, 2009, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NHK
- Device class
- 2
- Regulation
- 868.5905
- Medical specialty
- Anesthesiology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
| Mexico | 1 |
| Taiwan | 1 |
| Malaysia | 1 |
Makers of Resuscitator, Manual, Non Self-Inflating
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 2 | June 13, 1997 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 2 | June 13, 1997 | 0 | 0 | 0 | api.fda.gov |
| Galemed Corp. | WU-JIA Yilan, Taiwan | Manufacturer | 1 | November 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 1 | November 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 1 | November 3, 2000 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | February 11, 2002 | 0 | 0 | 0 | api.fda.gov |
| Plaxtron Industrial (M) Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunmed Ap, Ltd. | ZHUHAI Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 23, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.