Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
General Hospital — Predicate Candidate Screening
15,616 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
150 daysmedian FDA review time
339 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR- | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 | 140 | 0 |
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | 2026-08-05 | 142 | 0 |
| K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | 2026-08-04 | 252 | 0 |
| K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | 2026-07-29 | 57 | 0 |
| K260326 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Care | Datex-Ohmeda, Inc. | 2026-07-28 | 179 | 0 |
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | 2026-07-24 | 242 | 0 |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* | O&M Halyard, Inc. | 2026-07-21 | 36 | 0 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with C | Hartalega NGC Sdn. Bhd. | 2026-07-20 | 201 | 0 |
| K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026-07-15 | 131 | 0 |
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 | 171 | 0 |
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | 2026-07-10 | 101 | 0 |
| K260539 | MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ | MedSource Labs, LLC | 2026-07-09 | 142 | 0 |
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Tec | O&M Halyard, Inc. | 2026-07-02 | 27 | 0 |
| K253527 | Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGC | Covidien, LLC | 2026-07-01 | 230 | 0 |
| K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | 2026-06-24 | 85 | 0 |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Co | Sw Technologies, Inc. | 2026-06-24 | 352 | 0 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 | 199 | 0 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syring | Sol-Millennium Medical, Inc. | 2026-06-18 | 267 | 0 |
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | 2026-06-18 | 265 | 0 |
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | 2026-06-18 | 393 | 0 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with C | Hartalega NGC Sdn. Bhd. | 2026-06-17 | 92 | 0 |
| K260916 | FLEXI-PORT™ Power Injectable Implantable Port | Portal Access, Inc. | 2026-06-17 | 90 | 0 |
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2026-06-12 | 203 | 0 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Nee | CMT Health PTE., Ltd. | 2026-06-12 | 115 | 0 |
| K252987 | ADRx™ Admixture Device | Epic Medical Pte. , Ltd. | 2026-06-12 | 267 | 0 |
| K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | 2026-06-10 | 86 | 0 |
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); | Unimed Medical Supplies, Inc. | 2026-06-05 | 252 | 0 |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 | 126 | 0 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use | S&S Glove Corporation | 2026-06-03 | 91 | 0 |
| K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | 2026-06-03 | 90 | 0 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 | 83 | 0 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | 2026-06-03 | 268 | 0 |
| K261530 | iiSure Infusion Set | Deka Research and Development | 2026-06-03 | 26 | 0 |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | 2026-05-28 | 266 | 0 |
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Contain | Taizhou Huangyan Guanhong Plastic Steel Products Factory | 2026-05-22 | 177 | 0 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with | Hlb Lifescience Co., Ltd. | 2026-05-21 | 239 | 0 |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* | O&M Halyard, Inc. | 2026-05-18 | 227 | 0 |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | 2026-05-15 | 228 | 0 |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, B | Amsino International, Inc. | 2026-05-04 | 265 | 0 |
| DEN240075 | Prolystica Pass Thru Disinfectant Wipes | Steris | 2026-05-01 | 505 | 0 |
| K250680 | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | 2026-04-30 | 420 | 0 |
| K252471 | Paptizer 360 | LiViliti Health Products Corporation | 2026-04-29 | 266 | 0 |
| K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | 2026-04-24 | 452 | 0 |
| K260988 | °M Warmer System with °M Station | Mequ A/S | 2026-04-24 | 30 | 0 |
| K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), V | Steritec Products | 2026-04-22 | 272 | 0 |
| K253558 | Luminoah FLOW™ Enteral Nutrition System | Luminoah | 2026-04-20 | 154 | 0 |
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | 2026-04-17 | 28 | 0 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, | Chirana T.Injecta,A.S. | 2026-04-17 | 269 | 0 |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 | 107 | 0 |
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology | Advanced Sterilization Products, Inc. | 2026-04-15 | 219 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda