FDA Device Review Tracker
July 2026
FDA cleared 278 510(k)s, granted 5 De Novo requests and approved 4 original PMAs in July 2026; the median 510(k) took 103 days from receipt. FDA posted 8 Class I recall events.
The month in numbers
510(k) clearances
278
down 1% on a year earlier
De Novo grants
5
up 400% on a year earlier
Original PMA approvals
4
same as a year earlier
Median 510(k) review
103days
Prior 12 months: 130 days
266 of the month’s decisions name a predicate we could read; 43 have a Class I recall somewhere in their family tree.
New device types (De Novo)
- DEN250042CaRi-HeartCaristo Diagnostics, Ltd. · 2026Jul 28, 2026
- DEN250068OTTAVA™ Robotic Surgical SystemAuris Health, Inc., part of Johnson & Johnson MedTech · 2026Jul 21, 2026
- DEN250040SportSuite Vision SoftwareStryker Endoscopy · 2026Jul 17, 2026
- DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026Jul 6, 2026
- DEN250034Claria SystemClaria Medical, Inc. · 2026Jul 2, 2026
The predicates cited most this month
- K240536Wearable Breast Pump (Model S32)Shenzhen TPH Technology Co., Ltd. · 20242this month
- DEN230081Hearing Aid Feature (HAF)Apple, Inc. · 20242this month
- K233027NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 20232this month
- K253925Aventus Thrombectomy SystemInquis Medical · 20262this month
- K051218Modification to: Unicap Specific IgePharmacia Diagnostics AB · 20052this month
The deepest new lineages
- K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V. · 202640generations
- K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7…Samsung Medison Co., Ltd. · 202638generations
- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 202634generations
- K262094E3D™-C Interbody SystemEvolution Spine · 202634generations
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody…SeaSpine Orthopedics Corporation · 202633generations
Busiest product codes
- QIHAutomated Radiological Image Processing Software9decisions
- LLZSystem, Image Processing, Radiological8decisions
- OLOOrthopedic Stereotaxic Instrument6decisions
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic6decisions
- HRSPlate, Fixation, Bone5decisions
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar4decisions
Class I recall events (8)
- K191976BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered…Bard Access Systems, Inc. · Jul 30, 2026 · Component change controlClass I
- K232075StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.Nova Biomedical Corporation · Jul 29, 2026 · 5 products · Software designClass I
- Z-3106-2026Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP…Medical Action Industries, Inc. 306 · Jul 23, 2026 · 2 products · Nonconforming Material/ComponentClass I
- Z-3194-2026Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1…AVID Medical, Inc. · Jul 22, 2026 · Packaging process controlClass I
- Z-2979-2026BMC/REACTHEALTH Luna G3 APAP REF LG 3600BMC Medical Co., Ltd. · Jul 15, 2026 · No Marketing ApplicationClass I
- Z-3108-2026Halyard IV START KIT NON-STERILE REF: KRIV26-02AVID Medical, Inc. · Jul 14, 2026 · Packaging process controlClass I
- K230402Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number…Boston Scientific Corporation · Jul 9, 2026 · 2 products · Under Investigation by firmClass I
- K082689Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection…Spectra Medical Devices, Llc · Jul 6, 2026 · Nonconforming Material/ComponentClass I