twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.
twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. (New Hampshire): 510(k) cleared for Deka Research and Development Corp. Its amount of 80 is below the median of 138 (23rd percentile). Dated 20 days ago, it is in the active follow-up window. Score 36/100. 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: 80 · 23th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related NH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262576 |
| Device | twiist Loop Algorithm |
| Applicant | Deka Research and Development Corp. |
| Specialty / panel | Clinical Chemistry |
| Product code | QJI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-27 |
| Decision date | 2026-10-15 |
| Review time (days) | 80 |
| Third-party review | No |
| Applicant location | Manchester, NH, US |
| amount percentile | 23th of 414 (median 138, 0.6x median) |
| Peer records CSV (2 NH 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: 2026-10-15
- 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: twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. and 2 New Hampshire peers
- New Hampshire FDAPulse records like this one: 2
- twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.'s amount: 23rd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every New Hampshire peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 80-day review: this device is a strong predicate for similar products.
- Posted 20 days ago.
What is the FDAPulse record for twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. in New Hampshire?
twiist Loop Algorithm (K262576) by Deka Research and Development Corp. was cleared on 2026-10-15 after 80 days of review.
How does twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp. compare to other New Hampshire FDAPulse records?
Its amount of 80 is below the median (23th percentile); smaller records often move faster and face less competition. It is 20 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
twiist Loop Algorithm (K262576) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| twiist Loop Algorithm (K262576) | NH | 2026-10-15 |
| BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) | NJ | 2026-10-16 |
| EASYMAX Voice Blood Glucose Monitoring System (K261293) | TW | 2026-10-23 |
| Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857) | IL | 2026-10-21 |
Compare twiist Loop Algorithm (K262576) vs Instant-View® hCG Combo II Cassette Test (K262299) →
Compare twiist Loop Algorithm (K262576) vs Access BNP II (K262597) →
Related records
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- EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.
- Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc.
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- Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc.
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