Celerity HP Incubator
510(k) K190297
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190297 | Date14 May 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FRC
- Device class
- Class II
- Regulation
- 21 CFR Part 880.2800
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Celerity HP Incubator LCB046 is a tabletop device designed for incubating biological indicators, specifically the Celerity 20 HP Biological Indicator. It provides controlled heating to facilitate the germination and metabolic activity of test organisms for detection purposes, ensuring accurate validation of sterilization processes.
This device is supplied as a reusable, non-sterile unit intended for use in general hospital settings. It features an eight-well design with two independent heating blocks, each containing four wells equipped with status LEDs. The Celerity HP Incubator LCB046 holds an FDA 510(k) clearance under the classification of Class II medical devices (FRC product code) and is regulated under 21 CFR 880.2800.
Other devices from Steris Corporation
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Celerity HP Incubator LCB046 and how does it function in a sterilization validation process?
The Celerity HP Incubator LCB046 is designed specifically for incubating biological indicators, such as the Celerity 20 HP Biological Indicator, to support sterilization validation. It provides controlled heating to promote the germination and metabolic activity of test organisms within the indicators, enabling accurate detection of sterilization efficacy. This ensures that sterilization processes meet required standards by confirming the absence of viable microorganisms.
Is the Celerity HP Incubator reusable or single-use, and what does this mean for maintenance and cost?
The Celerity HP Incubator is a reusable, non-sterile unit, meaning it is intended for repeated use across multiple sterilization validation cycles. This design reduces ongoing costs by eliminating the need for disposable components, though it requires proper cleaning and maintenance between uses to ensure consistent performance and prevent cross-contamination.
How many wells does the incubator have, and what features help users monitor its operation?
The Celerity HP Incubator features an eight-well design, divided into two independent heating blocks with four wells each. Each well is equipped with a status LED, allowing users to visually monitor the operational status of the incubator and the progress of the biological indicators during incubation.
What regulatory pathway was followed for FDA clearance of this device, and what does this mean for its use in hospitals?
The Celerity HP Incubator received FDA clearance through a traditional 510(k) pathway, classified as a Class II medical device under the product code FRC. This clearance indicates it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in general hospital settings as outlined in 21 CFR 880.2800.