510(k) · Cleared

Cleared

Rpi Replacement Phototherapy Lights

K021531510(k) TraditionalCleared May 31, 200221-day reviewClass II21 CFR 880.5700

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

Replacement Parts Industries, Inc. · LBI Unit, Neonatal Phototherapy

Cleared on May 31, 2002 as substantially equivalent to K875270 (Air-Shields, Inc., 1988) and 4 other predicates after a 21-day review. Its family tree reaches back 1 generation to 1984.

Decided: May 31, 2002
Review: 21 days
Class: Class II
Product code: LBI
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K840454 (1984). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK840454 Phototherapy Unit 7850 Neonatal PhotoAir-Shields, Inc. · 1984
This deviceK021531 Rpi Replacement Phototherapy LightsReplacement Parts Industries, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K840454	Phototherapy Unit 7850 Neonatal Photo	Air-Shields, Inc.	1984	—
0 (this device)	K021531	Rpi Replacement Phototherapy Lights	Replacement Parts Industries, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1995	1	0
1997	1	0
2000	1	0

FIG. 1 — Lineage of K021531, 1984–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LBI? 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 LBI device

#1 K251308 SnugLit (TM) Wearable Phototherapy System…score 11.6 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K875270	Infant Intensive Care System Vertical Height Adjus Summary page 1 …for use to the following devices currently in commercial distribution: o Infant Intensive Care System, Free-Standing Infant Warmer, Air-Shields Inc., Hatboro, PA 19040; K875270 e Phototherapy System PTM78, Air-Shields, Inc., Hatboro, PA 19040; K840454 ¢ Duo-Light Phototherapy Unit, Air-Shields, Inc., Ha…	Air-Shields, Inc.	1988	—
*	K840454	Phototherapy Unit 7850 Neonatal Photo Summary page 1 …fant Intensive Care System, Free-Standing Infant Warmer, Air-Shields Inc., Hatboro, PA 19040; K875270 e Phototherapy System PTM78, Air-Shields, Inc., Hatboro, PA 19040; K840454 ¢ Duo-Light Phototherapy Unit, Air-Shields, Inc., Hatboro, PA 19040; K971256 e Resuscitaire Radiant Warmer, Hill-Rom Air-Shield…	Air-Shields, Inc.	1984	—
*	K971256	Duo-Lite Phototherapy System Summary page 1 …boro, PA 19040; K875270 e Phototherapy System PTM78, Air-Shields, Inc., Hatboro, PA 19040; K840454 ¢ Duo-Light Phototherapy Unit, Air-Shields, Inc., Hatboro, PA 19040; K971256 e Resuscitaire Radiant Warmer, Hill-Rom Air-Shields, Hatboro, PA 19040; K003335 and K940951 IV. DESCRIPTION The RPI Replacemen…	Air-Shields, Inc.	1997	—
*	K003335	Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted… Summary page 1 …PA 19040; K840454 ¢ Duo-Light Phototherapy Unit, Air-Shields, Inc., Hatboro, PA 19040; K971256 e Resuscitaire Radiant Warmer, Hill-Rom Air-Shields, Hatboro, PA 19040; K003335 and K940951 IV. DESCRIPTION The RPI Replacement phototherapy lights are intended to be used as replacement parts for various Hi…	Hill-Rom Air-Shields	2000	1
*	K940951	RW Resucitaire Infant Radiant Warmer Summary page 1 …840454 ¢ Duo-Light Phototherapy Unit, Air-Shields, Inc., Hatboro, PA 19040; K971256 e Resuscitaire Radiant Warmer, Hill-Rom Air-Shields, Hatboro, PA 19040; K003335 and K940951 IV. DESCRIPTION The RPI Replacement phototherapy lights are intended to be used as replacement parts for various Hill-Rom Air S…	Air-Shields, Inc.	1995	—

Also cleared against K875270: 1 other device →

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?

1 of the 5 ancestors has a recall of any class.
1 other device also cites its predicate K875270.

How does its category compare?

All LBI devices

LBI Unit, Neonatal Phototherapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBI

1in 2025

2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBI

134in 2016

2007high 157 (2011) · low 91 (2007)2026

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

Recalls per year · LBI

1in 2019

2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LBI

3in 2025

2007high 577 (2017) · low 0 (2023)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	91	0	1
2008	0	—	0	4
2009	2	—	1	4
2010	1	—	0	9
2011	3	157	0	5
2012	5	108	0	3
2013	0	—	0	6
2014	1	—	1	5
2015	1	—	1	6
2016	3	134	2	22
2017	2	—	0	577
2018	2	—	0	37
2019	1	—	1	6
2020	1	—	0	6
2021	1	—	0	2
2022	0	—	0	8
2023	0	—	0	0
2024	0	—	0	6
2025	1	—	0	3
2026	1	—	0	—

What is it indicated for?

RPI replacement phototherapy bulbs are designed to be used as replacement light bulbs for use with various phototherapy units and infant radiant warmers.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K021531 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021531: Rpi Replacement Phototherapy Lights.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021531

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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