510(k) K250022
- Device
- HeroTracker Sense
- Applicant
- Voluntis
- 510(k) number
- K250022
- Product code
- CAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-30
- Date received
- 2025-01-03
- Regulation
- 868.5630
- Classification name
- Nebulizer (Direct Patient Interface)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sana Charnine
- Address
- 58 Ave. De Wagram Paris FR 75017 75017
FDA Registration Numbers#
- 3010272829
- 3016731115
- 3011987967
- 1063407
- 3010892830
- 3008702754
- 8010042
- 3008789114
- 3013440654
- 3033482477
- 8022077
- 1423662
- 3033530347
- 9612777
- 3015772781
- 3008395118
- 3036830503
- 1417411
- 3006547005
- 3009057691
- 3001373226
- 3005587132
- 3031369651
- 3016088544
- 3005862821
- 3006852037
- 3010834934
- 2518443
- 9617604
- 3017207990
- 3007502289
- 9681848
- 2032112
- 9680741
- 8030673
- 8043439
- 3016360883
- 3018783526
- 2050098
- 8021995
- 1110315
- 3005910889
- 2518436
- 3001313714
- 9710644
- 3006606984
- 3029706818
- 3013053058
- 1417519
- 3003829675
- 3010047139
- 3017896419
- 9610861
- 3011189029
- 3003803075
- 1920664
- 1832562
- 3010594263
- 3007177643
- 2126519
- 1024404
- 3021244152
- 3009095356
- 1313525
- 3011716786
- 3014866140
- 3010402691
- 3014916466
- 3003399703
- 3003781173
- 3006446479
- 3003862188
- 3007344957
- 3012971441
- 3008806809
- 3005321947
- 9611451
- 8030245
- 2515872
Source Documents#
Other 510(k) Records For Product Code CAF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025-12-19 |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. | 2025-07-02 |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2025-06-20 |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | 2025-04-29 |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation | 2024-06-18 |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024-05-10 |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024-04-10 |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | 2024-01-04 |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 |
| K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023-10-31 |
| K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023-08-30 |
| K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation | 2023-08-24 |
| K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023-08-11 |