510(k) Report

FDA product code · General hospital

Implantable Radio Frequency Transponder System

NRVClass II21 CFR 880.6300510(k) exempt1 decision0 recalls

FDA lists NRV as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision. No recall names this code. The most-cited predicate is DEN040007, named by 3 later devices.

An implantable microtransponder system intended to facilitate access to identification and health information in humans. It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of NRV at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NRV

FDA has decided no NRV device since 2007.

Median 510(k) review, days · NRV

Too few NRV 510(k)s in any year since 2007 to give a median.

Recalls per year · NRV

No recall names NRV since 2007.

Adverse event reports per year · NRV

1in 2025

2007: 12008: 12009: 12015: 12018: 22022: 12025: 1
2007high 2 (2018) · low 0 (2010)2025

MAUDE reports naming product code NRV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—01
20090—01
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—02
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — NRV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NRV? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NRV devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN040007Implantable Radio Frequency Transponder System3cite it

Related product codes

Other codes under 21 CFR 880.6300.

PYQ Rfid Chip For Dental Appliance