TRANSWARMER— 510(k) K934631
Substantially EquivalentPrism Technologies, Inc.
FDA 510(k) clearance K934631 for TRANSWARMER, Substantially Equivalent on 1994-02-03. Applicant: Prism Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Prism Technologies, Inc.
- Product code
- Code IMD
- Device class
- Class 1
- Regulation
- 21 CFR 890.5710
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code IMD
view allMore clearances from Prism Technologies, Inc.
view allAdverse events under product code IMD
product code IMD- Death
- 3
- Injury
- 600
- Total
- 603
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 K934631
K-number listed on FDA's recall record- Z-2364-2019 — TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (when starting from 75 ) in 60 seconds or less. The product is sold in boxes of 6 Infant Transport Mattresses per box. The intended use of the product is to provide warmth during infant transport within the hospital or between hospitals.
- Z-1397-2015 — CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934631.
Data sourced from openFDA. This site is unofficial and independent of the FDA.