STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc.
STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc. (New Jersey): 510(k) cleared for Diagnostica Stago, Inc. Its amount of 244 is above the median of 138 (78th percentile). Dated 41 days ago, it serves as a historical benchmark. Score 66/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 244 · 78th percentile of 414 FDAPulse records · 1.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 17 related NJ FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260214 |
| Device | STA® - Liquid Anti-Xa |
| Applicant | Diagnostica Stago, Inc. |
| Specialty / panel | Other |
| Product code | KFF |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-01-23 |
| Decision date | 2026-09-24 |
| Review time (days) | 244 |
| Third-party review | No |
| Applicant location | Parsippany, NJ, US |
| amount percentile | 78th of 414 (median 138, 1.8x median) |
| Peer records CSV (18 NJ records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-24
- Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc. and 18 New Jersey peers
- New Jersey FDAPulse records like this one: 18
- STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc.'s amount: 78th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Jersey peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
66 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 244-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Special 510(k): a modification of an existing device.
- Posted 41 days ago.
What is the FDAPulse record for STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc. in New Jersey?
STA® - Liquid Anti-Xa (K260214) by Diagnostica Stago, Inc. was cleared on 2026-09-24 after 244 days of review.
How does STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc. compare to other New Jersey FDAPulse records?
Its amount of 244 sits in the upper half (78th percentile) of 414 records; the median is 138. It is 41 days old, still within a typical 45-day follow-up window.
STA® - Liquid Anti-Xa (K260214) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
| Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264) | CN | 2026-10-14 |
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