RPI Replacement Heating Elements
by Replacement Parts Industries, Inc.
510(k) K020966
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020966 | Date13 Jun 2002 | 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- Withdrawn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
- FMT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5130
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The RPI Replacement Heating Elements are designed as replacement components for infant radiant warmers, classified as a Warmer, Infant Radiant (Device Class II). These elements emit infrared radiant heat to maintain an infant’s body temperature, functioning identically to original equipment manufacturer parts.
These elements are supplied as reusable components for use in hospital settings, specifically within infant radiant warmers. They are not sterile at shipment and must be cleaned and maintained according to manufacturer instructions. The device holds an FDA 510(k) clearance under the Traditional pathway, with a K-number of K020966, and is regulated under regulation number 880.5130. No third-party certification is indicated.
Other devices from Replacement Parts Industries, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these heating elements intended for use in all infant radiant warmers, or are they compatible with specific models?
The RPI Replacement Heating Elements are designed to function identically to original equipment manufacturer (OEM) parts for infant radiant warmers, but compatibility depends on the specific model’s design requirements. While they are not explicitly listed as compatible with every model, their design aligns with the general standards for infant radiant warmers in hospital settings. Always verify compatibility with your existing warmer’s specifications before installation.
How should these heating elements be prepared for use in a clinical setting, given they are not sterile at shipment?
These elements are supplied as reusable components and are not sterile at shipment. They must be cleaned and maintained according to the manufacturer’s instructions to ensure safe and effective use in hospital settings. Proper cleaning protocols are critical to prevent contamination and maintain performance.
Are these heating elements intended for single-use or repeated use in a hospital environment?
The RPI Replacement Heating Elements are explicitly designed as reusable components for use in infant radiant warmers within hospital settings. Unlike single-use devices, they require regular cleaning and maintenance to ensure proper function and safety over multiple uses.
What regulatory pathway was followed for FDA clearance, and how does this affect their use in clinical settings?
These heating elements received FDA clearance under the Traditional 510(k) pathway, classified as substantially equivalent to a predicate device. This means they meet regulatory standards for infant radiant warmers (Device Class II) and are regulated under 21 CFR 880.5130. Their clearance does not alter clinical use requirements—proper cleaning, maintenance, and compatibility with the warmer remain essential for safe operation.
Do these elements come in different sizes or models, and how would a buyer determine the correct fit for their equipment?
The provided data does not specify distinct sizes or models beyond their general compatibility with infant radiant warmers. To ensure the correct fit, buyers should consult the manufacturer’s documentation or contact Replacement Parts Industries, Inc. directly, as the elements must match the original equipment manufacturer’s specifications for their specific warmer model.