Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.
Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc. (California): 510(k) cleared for Beta Bionics, Inc. Its amount of 252 is above the median of 138 (80th percentile). Dated 54 days ago, it serves as a historical benchmark. Score 55/100. 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: 252 · 80th percentile of 414 FDAPulse records · 1.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260001 |
| Device | Mint ACE Pump |
| Applicant | Beta Bionics, Inc. |
| Specialty / panel | Clinical Chemistry |
| Product code | QFG |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-02 |
| Decision date | 2026-09-11 |
| Review time (days) | 252 |
| Third-party review | No |
| Applicant location | Irvine, CA, US |
| amount percentile | 80th of 414 (median 138, 1.8x median) |
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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: 2026-09-11
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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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: Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.'s amount: 80th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 252-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc. in California?
Mint ACE Pump (K260001) by Beta Bionics, Inc. was cleared on 2026-09-11 after 252 days of review.
How does Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc. compare to other California FDAPulse records?
Its amount of 252 sits in the upper half (80th percentile) of 414 records; the median is 138. It is 54 days old; check the official source for later updates before acting.
Mint ACE Pump (K260001) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Mint ACE Pump (K260001) | CA | 2026-09-11 |
| Mint ACE Pump (K263422) | CA | 2026-10-21 |
| Instant-View® hCG Combo II Cassette Test (K262299) | CA | 2026-09-22 |
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