FDA Device Review Tracker
May 2026
FDA cleared 277 510(k)s, granted 4 De Novo requests and approved 5 original PMAs in May 2026; the median 510(k) took 147 days from receipt. FDA posted 17 Class I recall events.
The month in numbers
510(k) clearances
277
down 7% on a year earlier
De Novo grants
4
same as a year earlier
Original PMA approvals
5
up 67% on a year earlier
Median 510(k) review
147days
Prior 12 months: 127 days
271 of the month’s decisions name a predicate we could read; 44 have a Class I recall somewhere in their family tree.
New device types (De Novo)
The predicates cited most this month
- K232169FITBONE® Transport and Lengthening SystemOrthofix Srl · 20242this month
- K210136PhantomMSK HipOrthoGrid Systems, Inc. · 20212this month
- K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 20232this month
- K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 20212this month
- K241852Nasal Aspirator (NS 13)Avita Corporation · 20242this month
The deepest new lineages
- K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric…Senzime AB · 202639generations
- K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody…Carlsmed, Inc. · 202635generations
- K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 202631generations
- K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI) · 202631generations
- K261060Navigated LLIF Impactable TrackerTyber Medical, LLC · 202631generations
Busiest product codes
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic11decisions
- QIHAutomated Radiological Image Processing Software10decisions
- GEXPowered Laser Surgical Instrument8decisions
- LLZSystem, Image Processing, Radiological5decisions
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar5decisions
- OLOOrthopedic Stereotaxic Instrument5decisions
Class I recall events (17)
- Z-2463-2026Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with…Hamilton Medical AG · May 29, 2026 · Component design/selectionClass I
- K241708Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Abiomed, Inc. · May 22, 2026 · 4 products · Under Investigation by firmClass I
- P200046Medtronic Harmony Delivery Catheter SystemMedtronic Heart Valves Division · May 22, 2026 · Process controlClass I
- K192143Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number…Baxter Healthcare Corporation · May 21, 2026 · 4 products · Nonconforming Material/ComponentClass I
- Z-2619-2026A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…Windstone Medical Packaging, Inc. · May 21, 2026 · 4 products · Material/Component ContaminationClass I
- K231826Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2.…Insulet Corporation · May 20, 2026 · 3 products · Process designClass I
- P140003Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.Abiomed, Inc. · May 18, 2026 · Under Investigation by firmClass I
- K241156Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St.…Medline Industries, LP · May 15, 2026 · Under Investigation by firmClass I
- P140003Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled…Abiomed, Inc. · May 14, 2026 · Under Investigation by firmClass I
- Z-2792-2026Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic…Medical Action Industries, Inc. 306 · May 13, 2026 · Material/Component ContaminationClass I
- K123309Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001…Datex-Ohmeda Inc · May 8, 2026 · 3 products · Process controlClass I
- K230931Atlan A350XL. Model Number: 8621600. anesthesia workstationDraeger, Inc. · May 7, 2026 · 2 products · Process change controlClass I
- Z-2276-2026Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL…B Braun Medical Inc · May 6, 2026 · 3 products · Under Investigation by firmClass I
- Z-2455-2026Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2)…Medline Industries, LP · May 6, 2026 · 4 products · Nonconforming Material/ComponentClass I
- K183311Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Fresenius Kabi USA, LLC · May 6, 2026 · Device DesignClass I
- K183311LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Fresenius Kabi USA, LLC · May 6, 2026 · Software design (manufacturing process)Class I
- Z-2212-2026Pediatric care bed; Product Designation: KayserBett IDA;Kayserbetten GMBH & CO. KG · May 4, 2026 · Device DesignClass I