01
Identity map
02
Clearance context
- 510(k)
- K063758
- Device
- Concha Therm Neptune Heated Humidifier; model 425-00 / 425-00R
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-04-23
- Product code
- BTT
- Regulation
- 868.5450
- Specialty
- Anesthesiology
The FDA page contains legacy spelling variants in the device-name field. This sample normalizes the display name while preserving the source link.
03
Historic recall context
- Classification
- Class 2
- Recall
- Z-1040-2010
- Event
- 54232
- Initiated
- 2010-01-12
- Posted
- 2010-03-09
- Status
- Terminated on 2011-04-05
- Products
- 425-00, 425-10, and 525-30; all lots and serial numbers
- Reason
- When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.
- FDA cause
- Device Design
- Quantity
- 15,134 units
04
Analyst findings
Identifier match
The current GUDID record and the historic recall both identify catalog number 425-00.
Historic context
FDA classifies Z-1040-2010 as Class 2 and reports that it was terminated on 2011-04-05.
Current-status interpretation
The GUDID entry is marked in commercial distribution, but that fact alone does not establish current safety, availability, labeling revision, or recall status for any specific unit.
Required primary verification
Before commercial, clinical, or compliance use, verify the physical label, exact model/revision, current manufacturer documentation, and applicable FDA records.
05
Source ledger
| Source | Retrieved | Supports |
|---|---|---|
| AccessGUDID device record | 2026-08-16 | Device identity, catalog number, DI, company, distribution field |
| FDA 510(k) K063758 | 2026-08-16 | Clearance, classification, product code, decision date |
| FDA recall Z-1040-2010 | 2026-08-16 | Recall classification, dates, status, scope, reason, cause |
| openFDA device recall overview | 2026-08-16 | Dataset scope, update cadence, and responsible-use disclaimer |