FDAPulse / report
Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.
Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc. (Texas): 510(k) cleared for Monebo Technologies, Inc. Its amount of 238 is above the median of 138 (76th percentile). Dated 12 days ago, it is in the active follow-up window. Score 54/100. As of 2026-11-03, 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: 238 · 76th percentile of 414 FDAPulse records · 1.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related TX FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260640 |
| Device | Kinetic Software Library |
| Applicant | Monebo Technologies, Inc. |
| Specialty / panel | Cardiovascular |
| Product code | DPS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-27 |
| Decision date | 2026-10-23 |
| Review time (days) | 238 |
| Third-party review | No |
| Applicant location | Austin, TX, US |
| amount percentile | 76th of 414 (median 138, 1.7x median) |
| Peer records CSV (12 TX 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: 2026-10-23
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (TX first): MyoVista wavECG (DG-200-B15-003) (K260005) · Small Diameter Core Wire (CMAN-000-00); Small Diameter Core · SmartRead(TM) Medical Device Identifier (4100) (DEN260007) · DASH Flu A/B Test (K261347) · Ntegrate Threaded Nail System (K261961) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc. and 12 Texas peers
- Texas FDAPulse records like this one: 12
- Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.'s amount: 76th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Texas peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
54 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 238-day review, longer than typical.
- Posted 12 days ago.
What is the FDAPulse record for Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc. in Texas?
Kinetic Software Library (K260640) by Monebo Technologies, Inc. was cleared on 2026-10-23 after 238 days of review.
How does Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc. compare to other Texas FDAPulse records?
Its amount of 238 sits in the upper half (76th percentile) of 414 records; the median is 138. It is fresh: dated 12 days ago, inside the window where early outreach matters most.
Kinetic Software Library (K260640) vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| Kinetic Software Library (K260640) | TX | 2026-10-23 | This record |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 | Compare Kinetic Software Library (K260640) vs Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) → |
| MyoVista wavECG (DG-200-B15-003) (K260005) | TX | 2026-10-05 | Compare Kinetic Software Library (K260640) vs MyoVista wavECG (DG-200-B15-003) (K260005) → |
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