0.55% Orth-Phthalaldehyde Solution
FDA 510(k) K030004 · Advanced Sterilization Products
510(k) numberK030004
Submission
- Device name
- 0.55% Orth-Phthalaldehyde Solution
- Applicant
- Advanced Sterilization Products
Irvin, CA, US - Received
- January 2, 2003
- Decision date
- February 27, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
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| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | STERIS Corporation | 04/08/2026SE |
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| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…JOJ · Traditional | 07/05/2024SE |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104)…MLR · Traditional | 07/05/2024SE |
| K220404 | STERRAD NX with ALLClear TechnologyMLR · Traditional | 05/16/2022SE |
| K212174 | STERRAD 100NX Sterilizer with ALLClear TechnologyMLR · Traditional | 10/09/2021SE |
| K163598 | Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…KCT · Traditional | 07/31/2017SE |
| K162007 | STERRAD NX SterilizerMLR · Special | 02/16/2017SE |
| K160818 | STERRAD® NX Sterilizer with ALLClear TechnologyMLR · Traditional | 09/27/2016SE |
| K160903 | STERRAD 100NX Sterilizer with ALLClearTM TechnologyMLR · Traditional | 09/26/2016SE |
Questions and answers
When was 0.55% Orth-Phthalaldehyde Solution cleared by the FDA?
0.55% Orth-Phthalaldehyde Solution (K030004) received a 510(k) decision of Substantially Equivalent on February 27, 2003, 56 days after the submission was received.
What is the product code of K030004?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.