NLF · Oximeter, Reprocessed · Chrysalis Intelligence

Device class

Class II

Regulation 870.2700

Total clearances

2020-07-22 → 2024-10-22

Last 12 months

Unique sponsors

Definition

What is Oximeter, Reprocessed

same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.2700

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Stryker Sustainability Solutions	3	0	2024-10-22
Surgical Instrument and Savings Inc (Dba Medline Renewal)	1	0	2020-07-22

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
94760	CPT	—	Medium	Non-invasive ear or pulse oximetry for oxygen saturation monitoring
E0601	HCPCS	Continuous positive airway pressure (cpap) device ✓ CMS-verified description	Medium	Reprocessed oximetry equipment durable medical equipment

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2024-10-22	K241758	Stryker Sustainability Solutions	Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
2022-12-04	K222019	Stryker Sustainability Solutions	Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
2022-03-08	K211138	Stryker Sustainability Solutions	Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)
2020-07-22	K201699	Surgical Instrument and Savings Inc (Dba Medline Renewal)	Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor