Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309): 510(k) cleared for Ambu A/S
Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309): 510(k) cleared for Ambu A/S: 510(k) cleared for Ambu A/S. Its amount of 229 is above the median of 138 (72nd percentile). Dated 50 days ago, it serves as a historical benchmark. Score 42/100. 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: 229 · 72th percentile of 414 FDAPulse records · 1.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related DK FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260309 |
| Device | Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set |
| Applicant | Ambu A/S |
| Specialty / panel | Other |
| Product code | EOQ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-30 |
| Decision date | 2026-09-16 |
| Review time (days) | 229 |
| Third-party review | No |
| Applicant location | Ballerup, DK |
| amount percentile | 72th of 414 (median 138, 1.7x median) |
| Peer records CSV (4 DK records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-16
- Data refreshed: 2026-11-04
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Top FDAPulse records (DK first): Elos Accurate Hybrid Base (K261327) · Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400) · BoneXpert (K262390) · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · 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: Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309): 510(k) cleared for Ambu A/S and 4 DK peers
- DK FDAPulse records like this one: 4
- Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309): 510(k) cleared for Ambu A/S's amount: 72nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every DK peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 229-day review, longer than typical.
What is the FDAPulse record for Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309): 510(k) cleared for Ambu A/S?
Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309) by Ambu A/S was cleared on 2026-09-16 after 229 days of review.
How does Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309): 510(k) cleared for Ambu A/S compare to other FDAPulse records?
Its amount of 229 sits in the upper half (72th percentile) of 414 records; the median is 138. It is 50 days old; check the official source for later updates before acting.
Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set (K260309) | DK | 2026-09-16 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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