Sterile Water for Inhalation in 1L Flexoval ® bottles.
FDA 510(k) clearance K223551 · decided 2023-08-03
Clearance details
- K-number
- K223551
- Device name
- Sterile Water for Inhalation in 1L Flexoval ® bottles.
- Applicant
- Hometa, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-25
- Decision date
- 2023-08-03
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Albany, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| HVT 2.0 (K254078) | Vapotherm, Inc. | 2026-04-13 |
| FL-10000U Respiratory Humidifier (K251448) | Flexicare Medical Limited. | 2026-01-16 |
| Laboratorios Biogalenic Sterile Water for Inhalation, USP (K251419) | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 |
| Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (K253479) | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 |
| Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (K250312) | Medline Industries, LP | 2025-07-02 |
| Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (K251611) | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 |
| Laboratorios Biogalenic Sterile Water for Inhalation, USP (K242717) | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 |
| Hudson RCI Comfort Flo® CubCannula™ (K241778) | Medline Industries, LP | 2024-12-19 |
| Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (K240163) | Medline Industries, LP | 2024-09-27 |
| F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) (K234058) | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 |
| HFT150 (K233707) | Invent Medical Corporation | 2024-06-14 |
| F&P Optiflow Oxygen Kit (AA451J) (K233821) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 |
Recalls involving this device
No recalls on record reference this clearance.