STER-O-DOSE— 510(k) K820227
Substantially EquivalentInhalation Therapy Equipment, Co.
FDA 510(k) clearance K820227 for STER-O-DOSE, Substantially Equivalent on 1982-02-23. Applicant: Inhalation Therapy Equipment, Co.. Device class: 2.
Clearance details
- Applicant
- Inhalation Therapy Equipment, Co.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CAF
view allMore clearances from Inhalation Therapy Equipment, Co.
view allAdverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K820227
K-number listed on FDA's recall record- Z-0719-2019 — Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
- Z-0720-2019 — Portex Unit Dose 15 ml Normal Saline ¿
- Z-0721-2019 — Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K820227.
Data sourced from openFDA. This site is unofficial and independent of the FDA.