DeviceClearance

Product code LRO— General, Plastic Surgery

1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT

Classification name
General Surgery Tray
Device class
Class 2
Regulation
21 CFR 878.4370
Advisory panel
General, Plastic Surgery
Total cleared
110
First cleared
Most recent

FDA classification definition

“This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance”

— U.S. Food and Drug Administration, device classification record for product code LRO under 21 CFR 878.4370, via openFDA

Market context for product code LRO

FDA has cleared 110 devices under product code LRO between 1984 and 2022, filed by 71 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LRO

Adverse events under product code LRO

product code LRO
Injury
975
Malfunction
14,038
Other
2
Total
15,015

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LRO

1–100 of 110

Data sourced from openFDA. This site is unofficial and independent of the FDA.