SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000— 510(k) K040632
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K040632 for SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000, Substantially Equivalent on 2004-04-27. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rockland, MA, US
Recent devices under product code DWJ
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view all- K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
- K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
- K211634 — Hypodermic Needle-Pro EDGE Safety Device
- K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets
- K181699 — Level 1 Convective Warmer
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
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 K040632
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040632.
Data sourced from openFDA. This site is unofficial and independent of the FDA.