NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical
NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical (Illinois): 510(k) cleared for ICU Medical. Its amount of 58 is below the median of 138 (15th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 30/100. 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: 58 · 15th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262532 |
| Device | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) |
| Applicant | ICU Medical |
| Specialty / panel | General Hospital |
| Product code | LGZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-22 |
| Decision date | 2026-09-18 |
| Review time (days) | 58 |
| Third-party review | No |
| Applicant location | Lake Forest, IL, US |
| amount percentile | 15th of 414 (median 138, 0.4x median) |
| Peer records CSV (57 IL 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: 2026-09-18
- Data refreshed: 2026-11-04
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Top FDAPulse records (IL first): SmartIPL_NI System (K241973) · Hyperdrive 35 Guidewire (K253146) · Tempus ECG-MR (K254297) · Ecomed Disposable Administration Sets (K254123) · TumorSight Risk (K260023) · Browse all by state and category →
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: NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical's amount: 15th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 58-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical in Illinois?
NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532) by ICU Medical was cleared on 2026-09-18 after 58 days of review.
How does NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical compare to other Illinois FDAPulse records?
Its amount of 58 is below the median (15th percentile); smaller records often move faster and face less competition. It is 48 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532) | IL | 2026-09-18 |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| Endox High Level Disinfectant (K254094) | DE | 2026-10-16 |
| Carecube Negative Pressure Isolation Chamber (1BY) (K260180) | CA | 2026-10-16 |
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