510(k) Report

510(k) · Cleared

Cleared

Neurorecovery, Inc. (Nri) Comprehensive Intracranial Pressure Evaluation and Relief (Ciper) Kit

K051599510(k) TraditionalCleared Jul 19, 200533-day reviewClass II21 CFR 882.1620

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

Neurorecovery, Inc. · GWM Device, Monitoring, Intracranial Pressure

Cleared on Jul 19, 2005 as substantially equivalent to K822864 (Medex, Inc., 1982) and 1 other predicate after a 33-day review. Its family tree reaches back 1 generation to 1982.

Decided
Jul 19, 2005
Review
33 days
Class
Class II
Product code
GWM
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K822864 (1982). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK822864 · Intracranial Pressure Monitoring Device · Medex, Inc. · 1982 · recalled198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K822864 · Intracranial Pressure Monitoring Device · Medex, Inc. · 1982 · recalled0
  1. Root · 1 generation backK822864 Intracranial Pressure Monitoring DeviceMedex, Inc. · 1982 · Recalled
  2. This deviceK051599 Neurorecovery, Inc. (Nri) Comprehensive Intracranial Pressure…Neurorecovery, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K822864Intracranial Pressure Monitoring DeviceMedex, Inc.19821
0 (this device)K051599Neurorecovery, Inc. (Nri) Comprehensive Intracranial Pressure Evaluation and…Neurorecovery, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K051599, 1982–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GWM device

  1. #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K822864Intracranial Pressure Monitoring Device
Summary page 1
…CFR 882.1620; ProCode: GWM) have been classified as Class II devices. 4. PREDICATE DEVICES * Medex, Inc. Intracranial Pressure Monitoring Device (K822864) * Medex, Inc. Transtar Intracranial Pressure Transducer (K020780) NeurorecoveryT M , Inc., July 11…
Medex, Inc.19821
*K020780Transtar Intracranial Pressure Transducer, Model MX950ICP
Summary page 1
…s. 4. PREDICATE DEVICES * Medex, Inc. Intracranial Pressure Monitoring Device (K822864) * Medex, Inc. Transtar Intracranial Pressure Transducer (K020780) NeurorecoveryT M , Inc., July 11, 2005 Response to Request for Additional Information:…
Medex, Inc.20022

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 2 ancestors have a recall of any class.

How does its category compare?

All GWM devices

GWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWM

1in 2025

2007: 22008: 22009: 12010: 22011: 32012: 42013: 22014: 22016: 32017: 32018: 12019: 22020: 32021: 22024: 22025: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWM

30in 2020

2011: 123 days median2012: 100 days median2016: 192 days median2017: 37 days median2020: 30 days median
2007high 192 (2016) · low 30 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWM

3in 2025

2008: 12010: 92011: 62012: 12013: 122014: 22019: 12023: 1, 1 Class I2024: 4, 2 Class I2025: 3
2007high 12 (2013) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · GWM

441in 2025

2007: 1262008: 1052009: 1172010: 1042011: 1842012: 1512013: 1202014: 3602015: 4862016: 4192017: 4452018: 3022019: 2602020: 2682021: 2112022: 4242023: 7442024: 6412025: 441
2007high 744 (2023) · low 104 (2010)2025

MAUDE reports naming product code GWM, 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
20072—0126
20082—1105
20091—0117
20102—9104
201131236184
201241001151
20132—12120
20142—2360
20150—0486
201631920419
20173370445
20181—0302
20192—1260
20203300268
20212—0211
20220—0424
20230—1 (1)744
20242—4 (2)641
20251—3441
20261—0—

What is it indicated for?

The Neurorecovery™, Inc., Neurorecovery Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure.

Indications for use as stated in the FDA summary.

More from Neurorecovery, Inc.

2 FDA decisions under this applicant name. See the company

  • K022638Neurorecovery Ventricular Catheter & Main Valve Assembly KitNeurorecovery, Inc. · 2002

Recent decisions in GWM

The GWM category page

  • K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa · 2026
  • K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003); Neurovent-Ifd-S…Raumedic AG · 2025
  • K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A. · 2024
  • K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation · 20241 Class I recall
  • K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2021

https://510kreport.com/device/K051599 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051599: Neurorecovery, Inc. (Nri) Comprehensive Intracranial Pressure Evaluation and Relief (Ciper) Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051599

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026