FDAPulse / report
H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.
H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.: 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd. Its amount of 232 is above the median of 138 (74th percentile). Dated 33 days ago, it serves as a historical benchmark. Score 48/100. 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: 232 · 74th percentile of 414 FDAPulse records · 1.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260468 |
| Device | H100Plus Hemoglobin Testing System |
| Applicant | Shenzhen Lifotronic Technology Co., Ltd. |
| Specialty / panel | Clinical Chemistry |
| Product code | PDJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-12 |
| Decision date | 2026-10-02 |
| Review time (days) | 232 |
| Third-party review | No |
| Applicant location | Shenzhen, CN |
| amount percentile | 74th of 414 (median 138, 1.7x median) |
| Peer records CSV (76 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co. + all 76 CN records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
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: 2026-10-02
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · 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
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.'s amount: 74th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 232-day review, longer than typical.
- Posted 33 days ago.
What is the FDAPulse record for H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.?
H100Plus Hemoglobin Testing System (K260468) by Shenzhen Lifotronic Technology Co., Ltd. was cleared on 2026-10-02 after 232 days of review.
How does H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd. compare to other FDAPulse records?
Its amount of 232 sits in the upper half (74th percentile) of 414 records; the median is 138. It is 33 days old, still within a typical 45-day follow-up window.
H100Plus Hemoglobin Testing System (K260468) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| H100Plus Hemoglobin Testing System (K260468) | CN | 2026-10-02 |
| 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 |
Related records
- BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company
- 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.
- Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.
- CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.
- VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd.
- Mint ACE Pump (K263422): 510(k) cleared for Beta Bionics, Inc.
- Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.
- twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.
- Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.
- Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc.
- Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Clinical Chemistry devices
How to monitor H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd. and peer clinical chemistry records
Get new FDAPulse records like H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.