Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.
Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. (Pennsylvania): 510(k) cleared for Aesculap, Inc. Its amount of 268 is top-decile (90th percentile of 414 records). Dated 34 days ago, it serves as a historical benchmark. Score 61/100. 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: 268 · 90th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260044 |
| Device | Ventricular Catheters, Thomale Catheter |
| Applicant | Aesculap, Inc. |
| Specialty / panel | Neurology |
| Product code | JXG |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-07 |
| Decision date | 2026-10-02 |
| Review time (days) | 268 |
| Third-party review | No |
| Applicant location | Center Valley, PA, US |
| amount percentile | 90th of 414 (median 138, 1.9x median) |
| Peer records CSV (19 PA records) | 🔒 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: 2026-10-02
- 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: Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.'s amount: 90th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 268-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 34 days ago.
What is the FDAPulse record for Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. in Pennsylvania?
Ventricular Catheters, Thomale Catheter (K260044) by Aesculap, Inc. was cleared on 2026-10-02 after 268 days of review.
How does Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. compare to other Pennsylvania FDAPulse records?
This is a top-decile record: its amount of 268 is 1.9x the median of 138 across 414 records. It is 34 days old, still within a typical 45-day follow-up window.
Ventricular Catheters, Thomale Catheter (K260044) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ventricular Catheters, Thomale Catheter (K260044) | PA | 2026-10-02 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
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