FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
K Number: K040208
·
Decision May 11, 2004
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
15
Review Days
102
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
- K Number
- K040208
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tz Medical, Inc.
- Date Received
- January 30, 2004
- Decision Date
- May 11, 2004
- Product Code
- QSY
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QSY), ordered by most recent decision date.
BloodSTOP iX Trauma Matrix (TM-iX-20)
FDA 510(k)
FDA Unclassified
·Unknown
Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm
FDA 510(k)
FDA Unclassified
·Unknown
MFUSE (MS001)
FDA 510(k)
FDA Unclassified
·Unknown
TRAUMAGEL® 2.0 Hemostatic Gel
FDA 510(k)
FDA Unclassified
·Unknown
TRAUMAGEL®
FDA 510(k)
FDA Unclassified
·Unknown
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Tz Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252772 | Arc Adjustable Radial Cuff Compression Device | May 22, 2026 | Substantially Equivalent |
| K173563 | ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE | Jan 10, 2018 | Substantially Equivalent |
| K163322 | TZ SKULL PIN Adult | Feb 23, 2017 | Substantially Equivalent |
| K102507 | AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR | Jun 13, 2011 | Substantially Equivalent |
| K062577 | V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC | Dec 15, 2006 | Substantially Equivalent |
| K021421 | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE | Apr 18, 2003 | Substantially Equivalent |
| K001634 | CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 | Dec 21, 2000 | Substantially Equivalent |
| K993205 | BOOKER BOX, MODEL PAD 5010 | Jul 20, 2000 | Substantially Equivalent |
| K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | Sep 15, 1999 | Substantially Equivalent |
| K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | Sep 15, 1999 | Substantially Equivalent |