Data / Medical devices / United States / Munchkin Inc.
Munchkin Inc.: FDA-registered device maker in Van Nuys, CA, United States, 2 510(k) clearances
Munchkin Inc. is registered with the FDA (registration 3000215556) in Van Nuys, CA, United States. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 10, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000215556
- Address
- 7835 Gloria Ave, Van Nuys, CA, United States, 91406
- Owner or operator
- Munchkin Inc. (10028219)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- January 8, 2009
- Registered through
- 2026
- Brand names listed
- Clear Nose Nasal Aspirator, HYPO3 Munchkin Daily Diaper Rash Spray, HYPO3 Munchkin Daily Diaper Rash Spray - Sample, HYPO3 Munchkin Eczema Spray, Hot/Cold Breast Therapy Gel Pack, Munchkin Flow, Munchkin Inc, Munchkin SIlicon Breast Pump and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 10, 2021 | K201600 | Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 | FLL | Substantially Equivalent | Kangfu Medical Equipment Factory | accessdata.fda.gov |
| June 10, 2016 | K160095 | Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz | FRO | Substantially Equivalent | Simple Science, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Dressing, Wound, Drug
- All makers of Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
- All makers of Massager, Therapeutic, Electric
- All makers of Shield, Nipple
- All makers of Container, Liquid Medication, Graduated
Updated December 10, 2021. 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.