FDA product code · General Hospital
LHISet, I.V. Fluid Transfer
Product code LHI covers Set, I.V. Fluid Transfer, a Class II device regulated under 21 CFR 880.5440. FDA has cleared 206 devices in this code, 5 of them in the last 12 months. Median review time across the 206 most recent decisions is 89 days. openFDA lists 61 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.5440
- Review panel
- General Hospital
- Clearances
- 206
What is happening in LHI right now?
LHI (Set, I.V. Fluid Transfer) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Epic Medical Pte. , Ltd. and Asset Medikal (K252987, K251715, K251676). The code is crowded, scoring 79 of 100 — 99 companies hold a clearance here and 5 arrived in the last 12 months (LHI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252987, K251715, K251676 |
| Crowding | Context | LHI:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in LHI?
FDA has cleared 206 devices under product code LHI since the 510(k) programme began in 1976, 5 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252987 | ADRx Admixture Device | Epic Medical Pte. , Ltd. | |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | |
| K250345 | Medline Bag Decanter | Medline Industries, LP | |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | |
| K243404 | HyHub and HyHub Duo Vial Access Devices | Takeda Pharmaceuticals | |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | |
| K243985 | Rio Drug Reconstitution Transfer Device | Icu Medical, Inc. | |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | |
| K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH |
How long does FDA review take for LHI?
The median FDA review time for LHI is 89 days, measured across the 206 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in LHI?
openFDA lists 61 recall records against product code LHI. A recall record covers one firm's corrective action and may span many device lots.
Z-1532-2025Open, ClassifiedOmnicell, Inc.
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
Z-0283-2025Open, ClassifiedWest Pharmaceutical Services AZ, Inc.
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Z-3082-2024Open, ClassifiedBaxter Healthcare Corporation
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Z-3083-2024Open, ClassifiedBaxter Healthcare Corporation
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Z-3084-2024Open, ClassifiedBaxter Healthcare Corporation
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Showing the 5 most recently initiated of 61. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for LHI?
MAUDE holds 3,833 adverse-event reports naming product code LHI, 1,096 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in LHI unusual?
One month sits above LHI's own expected range: 1 November 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 98 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 96 | Insufficient history | No expected range — too little history | |
| 73 | Insufficient history | No expected range — too little history | |
| 93 | Insufficient history | No expected range — too little history | |
| 71 | Insufficient history | No expected range — too little history | |
| 79 | Insufficient history | No expected range — too little history | |
| 66 | Insufficient history | No expected range — too little history | |
| 95 | Insufficient history | No expected range — too little history | |
| 52 | Insufficient history | No expected range — too little history | |
| 79 | Insufficient history | No expected range — too little history | |
| 77 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 84 | Insufficient history | No expected range — too little history | |
| 123 | Insufficient history | No expected range — too little history | |
| 96 | Insufficient history | No expected range — too little history | |
| 74 | Insufficient history | No expected range — too little history | |
| 119 | Insufficient history | No expected range — too little history | |
| 205 | Insufficient history | No expected range — too little history | |
| 131 | Insufficient history | No expected range — too little history | |
| 170 | Insufficient history | No expected range — too little history | |
| 59 | 49–206 | Within expected (49–206) | |
| 127 | 27–160 | Within expected (27–160) | |
| 95 | 39–193 | Within expected (39–193) | |
| 115 | 35–191 | Within expected (35–191) | |
| 72 | 39–175 | Within expected (39–175) | |
| 94 | 29–172 | Within expected (29–172) | |
| 96 | 43–265 | Within expected (43–265) | |
| 92 | 15–191 | Within expected (15–191) | |
| 99 | 16–196 | Within expected (16–196) | |
| 117 | 13–195 | Within expected (13–195) | |
| 186 | 31–162 | Above expected (31–162) | |
| 172 | 50–225 | Within expected (50–225) | |
| 201 | 71–266 | Within expected (71–266) | |
| 122 | 72–233 | Within expected (72–233) | |
| 116 | 73–239 | Within expected (73–239) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in LHI.
Who has entered LHI in the last year?
3 companies filed in LHI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Epic Medical Pte. , Ltd. | K252987 | |
| Asset Medikal | K251715 | |
| Microtek Medical, Inc. | K251676 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in LHI?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in LHI?
Across the 206 most recent decisions, these applicants filed most often in LHI.
| Applicant | Recent clearances |
|---|---|
| Medimop Medical Projects, Ltd. | 11 |
| Baxter Healthcare Corp | 10 |
| B.Braun Medical, Inc. | 9 |
| Baxa Corp., Sub. of Cook Group, Inc. | 7 |
| Carmel Pharma Ab. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in LHI file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Baxter Healthcare Corporation | 12 | 2 |
| Baxa Corporation | 10 | 2 |
| Yukon Medical, LLC | 8 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch LHI
Get an email the morning anything changes in LHI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in General Hospital
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.